Hot FlashesPhase 4NCT00245518
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
A Phase 4 study testing Isoflavone in people with Hot Flashes, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Isoflavone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men > or =21 with prostate CA and hypogonadism for at least 3 months
Who cannot join
- on growth promoting agents
- on appetite stimulating agents
- on Prednisone and others
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Clinical Trials Unit
Baltimore, Maryland, 21205
About this study
Official title: Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.
Read the detailed description
This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.
- Conditions
- Hot Flashes
- Being tested
- Isoflavone, Placebos
- Keywords
- prostate cancer, soy, androgen deprivation, quality of life, isoflavones
- Medical subject headings
- Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoflavoneDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Isoflavone | Experimental | Isoflavone Receives: Drug: Isoflavone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function as Assessed by the National Adult Reading Test (NART)
the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.
Measured: baseline, 6 weeks, 12 weeks
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score
The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
Measured: baseline, 6 weeks, 12 weeks
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index
The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.
Measured: baseline, 6 weeks, 12 weeks
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained
The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.
Measured: baseline, 6 weeks, 12 weeks
Cognitive Function as Assessed by the F-A-S Test
The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)
Measured: baseline, 6 weeks, 12 weeks
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.
Measured: baseline, 6 weeks, 12 weeks
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Measured: baseline, 6 weeks, 12 weeks
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Measured: baseline, 6 weeks, 12 weeks
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Measured: baseline, 6 weeks, 12 weeks
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall
The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:
- Correct Image: placed properly (2 points), placed poorly (1 point)
- Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
- Absent or not recognizable: 0 points
Scale ranges 0-36. with 36 being greatest cognitive function.
Measured: baseline, 6 weeks, 12 weeks
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall
The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:
- Correct Image: placed properly (2 points), placed poorly (1 point)
- Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
- Absent or not recognizable: 0 points
Scale ranges 0-36, with 36 representing maximum cognition .
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score
The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from "always" to "never" is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido
The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function
The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal
The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification
The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.
Measured: baseline, 6 weeks, 12 weeks
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.
Measured: baseline, 6 weeks, 12 weeks
Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: baseline, 6 weeks, 12 weeks
Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)
Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.
Measured: baseline, 6 weeks, 12 weeks
Mental Health as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Physical Health as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Fatigue as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Physical Functioning as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Body Pain as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
General Health Perceptions as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Physicians Laboratories, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shehzad Basaria, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245518
- Sponsor's protocol ID
- 04-08-09-04
- Status last verified
- Sep 2017
- First submitted
- 26 Oct 2005
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT00245518
- Acronym / sponsor ID
- 04-08-09-04
- Conditions
- Hot Flashes
- Keywords
- prostate cancer, soy, androgen deprivation, quality of life, isoflavones
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Physicians Laboratories, National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Oct 2005 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.
Detailed description
This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoflavone | Experimental | Drug: IsoflavoneIsoflavone |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men > or =21 with prostate CA and hypogonadism for at least 3 months
Key exclusion criteria (3 listed)
- on growth promoting agents
- on appetite stimulating agents
- on Prednisone and others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoflavone | Drug | Isoflavone |
| Placebos | Drug | Placebo |
Primary outcome
Cognitive Function as Assessed by the National Adult Reading Test (NART)
Time frame: baseline, 6 weeks, 12 weeks
the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score
Time frame: baseline, 6 weeks, 12 weeks
The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index
Time frame: baseline, 6 weeks, 12 weeks
The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained
Time frame: baseline, 6 weeks, 12 weeks
The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.
Cognitive Function as Assessed by the F-A-S Test
Time frame: baseline, 6 weeks, 12 weeks
The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)
Time frame: baseline, 6 weeks, 12 weeks
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)
Time frame: baseline, 6 weeks, 12 weeks
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops
Time frame: baseline, 6 weeks, 12 weeks
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops
Time frame: baseline, 6 weeks, 12 weeks
The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall
Time frame: baseline, 6 weeks, 12 weeks
The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points: 1. Correct Image: placed properly (2 points), placed poorly (1 point) 2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point 3. Absent or not recognizable: 0 points Scale ranges 0-36. with 36 being greatest cognitive function.
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall
Time frame: baseline, 6 weeks, 12 weeks
The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points: 1. Correct Image: placed properly (2 points), placed poorly (1 point) 2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point 3. Absent or not recognizable: 0 points Scale ranges 0-36, with 36 representing maximum cognition .
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score
Time frame: baseline, 6 weeks, 12 weeks
The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from "always" to "never" is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido
Time frame: baseline, 6 weeks, 12 weeks
The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function
Time frame: baseline, 6 weeks, 12 weeks
The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal
Time frame: baseline, 6 weeks, 12 weeks
The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification
Time frame: baseline, 6 weeks, 12 weeks
The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score
Time frame: baseline, 6 weeks, 12 weeks
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function
Time frame: baseline, 6 weeks, 12 weeks
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction
Time frame: baseline, 6 weeks, 12 weeks
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function
Time frame: baseline, 6 weeks, 12 weeks
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire
Time frame: baseline, 6 weeks, 12 weeks
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction
Time frame: baseline, 6 weeks, 12 weeks
IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.
Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)
Time frame: baseline, 6 weeks, 12 weeks
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)
Time frame: baseline, 6 weeks, 12 weeks
Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.
Mental Health as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Physical Health as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Fatigue as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Physical Functioning as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Body Pain as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
General Health Perceptions as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
Time frame: baseline, 6 weeks, 12 weeks
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shehzad Basaria, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isoflavone in people with Hot Flashes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function as Assessed by the National Adult Reading Test (NART) (time frame: baseline, 6 weeks, 12 weeks). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.