AnorexiaPhase 2NCT00558558
Haelan and Nutrition in Cancer Patients
A Phase 2 study testing Haelan in people with Anorexia and Weight Loss, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary: To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anorexia, Weight Loss, Cachexia
- What is being tested?
- Haelan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2009
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anorexia (defined as > 30mm on a visual analog scale [VAS] of 0 to 100mm)
- Weight loss (defined as weight loss > 5% within last 6 months)
- Normal cognition (per treating physician's opinion)
- Written informed consent
- Advanced solid tumor (defined as locally recurrent or metastatic disease)
- Patient must have perceived weight loss as a problem.
- Able to maintain oral food intake within one week prior to enrollment in this study.
Who cannot join
- Evidence of ascites (per treating physician's opinion).
- Receiving supplementary tube feedings or parenteral nutrition
- Known mechanical obstruction of the alimentary tract, or intractable vomiting
- Add or change dose of the following medication within 2 weeks prior to this trial or during this trial: megestrol, corticosteroid, mirtazapine, metoclopramide and dronabinol, with the exception of pre-medication for chemotherapy (10-20 mg Decadron intavenous (IV) once and/or Reglan 10 mg IV x1 prior to chemotherapy).
- Allergic to soy.
- Positive pregnancy test for female patients of child-bearing potential. (Definition of child-bearing potential: not post-menopausal for past 12 months or nor surgically sterile)
Show all 10Show fewer
- Female patients with child bearing potential, but refuse to practice accepted methods of contraception (acceptable forms of contraception include: continuous abstinence, Depo-Provera shot, tubal ligation, NuvaRing vaginal ring, Ortho Evra skin patch, oral contraceptive, IUD-Mirena, vasectomy, male condom, diaphragm).
- Weight less than 80 lb.
- Patient who could not tolerate oral intake of 2 Oz. of Haelan during the taste test.
- Diagnosed of breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study Examining the Role of Fermented Soy Beverage for Improving Cancer-Associated Anorexia and Cachexia
Primary:
- To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
- To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
- To determine if treatment with Haelan can increase patient's calorie intake, albumin, pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence analysis), and weight at week 4+/- 5 days.
- To determine if treatment with Haelan can decrease patient's Functional assessment of anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days.
- To assess the feasibility of accrual, and adherence to the Haelan consumption.
Read more
Secondary:
- Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients.
- Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with primary outcome in these patients.
- To determine if treatment with Haelan can increase patient's functional status at week 4+/- 5 days.
Read the detailed description
Individuals who have cancer-related malnutrition have also been found to have a higher risk of complications and are less able to tolerate the side effects of conventional therapies such as chemotherapy, radiation, and surgery.
Haelan is a soy-based liquid (beverage). It contains large amount of isoflavones. Isoflavones inhibit "nuclear factor-kappa B," which may lead to prevention of weight loss.
If you are eligible to take part in this study, you will then be given 2 fluid ounces of Haelan, as a taste test. If you are not able to tolerate the taste of Haelan, you will not be eligible for this study.
If you are able to pass the taste test and you are a woman who is able to have children, you will be asked to have a pregnancy test 24 hours prior to registration to Part B. Then only if you test negative for the pregnancy test will you be considered eligible for this study. If you are a female patient and refuse to practice accepted methods of contraceptives during the study, you will not be eligible for this study.
If you are still eligible for this study, you will have about 6 teaspoons of blood drawn, for baseline routine tests. Your height and weight will be measured. You will be instructed by a research nurse to recall your one day food intake before starting treatment. You will be asked about any medications you are taking (especially any appetite stimulants, such as megestrol, corticosteroid, and marinol), including the dose and when you take them. If you are able to tolerate the taste of Haelan, you will be instructed to drink 4 ounces of Haelan soy beverage 2 times a day, on an empty stomach, for 8 weeks. You may add water, stevia, honey or artificial sweeteners into Haelan prior to drinking it to improve the tolerance of Haelan. If you are unable to tolerate 4 ounces of Haelan twice a day after 2 attempts, the dose will be reduced to 2 ounces twice a day. If you are still not able to tolerate it after 2 attempts, the dose will be reduced again to 1 ounce twice a day. If you still cannot tolerate drinking this Haelan dose after 2 more attempts, the dose will be reduced again to 1 ounce daily. If you cannot tolerate at least 1 ounce a day for 5 consecutive days, you will be taken off this study. If you vomit within half hour of taking the Haelan, you should try at least 2 more times to drink at least 1 ounce of Haelan on the same day. If unsuccessful, please record that you were not able to take the Haelan on that day. If you cannot tolerate at least 1 ounce of Haelan a day for 5 days in a row, you will be taken off this study.
If you are able to pass the taste test and if you are a female with child-bearing potential you will be asked to have a pregnancy test 24 hours prior to registration to Part B .
You will be asked to write down how many ounces of Haelan you are able to drink at each dose and each day, in a study-drug diary. You will be asked to write down the side effect of Haelan daily.
You will be asked to write down the side effect of Haelan daily. You will have about 6 teaspoons of blood drawn for routine clinical tests, for protein level and kidney function at Week 4 +/- 5 days. You will also be asked to complete 3 questionnaires that have questions about any appetite, nausea, and fatigue you experience and your overall sense of well being. These questionnaires will take about 15 minutes to complete. You will be given several tests to measure your weight, skin-fold thickness and body composition. You will be given 2 functional tests, which involves timing how long it takes for you to get up from a chair to walk and timing how long it takes for you to walk 50 feet at your fastest speed. These tests will take about 30 minutes to complete. The questionnaires, measurement of your weight, skin-fold thickness and body composition, and functional tests will be done before treatment starts and on a visit day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days.
You will also be instructed by a research nurse to record your food intake, for one day in day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days.
During this study, you will have several tests performed to check for safety and effectiveness. Every 2 weeks, you will be asked if you are experiencing any side effects, either related or not related to the treatment. You will be asked about any medications you are taking, including the dose levels and when you take them.
You will be asked to bring the Haelan intake diary back to clinic on the study visits between day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days, so the study staff can record how many ounces of Haelan you have taken every day.
At the end of Haelan soy beverage treatment (week 8 +/- 5 days), you will be asked to return to the clinic for a end-of-treatment visit. You will have blood drawn (about 6 teaspoons) for routine clinic tests to detect for protein level and kidney function. Your study-drug diary will be checked, and you will again be given the questionnaires. Measurement of your weight, skin-fold thickness and body composition, and functional tests will be given. You will be asked about any medications you are taking, including the dose levels and when you take them. You will also be asked to provide the research nurse with the record of one day food intake at 8 weeks +/- 5 days. The one day food intake record should be finished before coming in for your clinic visit, as long as it is the recording of the 8th week food intake. However, if the 8th-week clinic visit is on the first day of the 8th week, you can continue to record your food intake after the visit, and then return it to the research nurse at a later time. For this record, you need to write down what type of food you eat, and the estimated portion (for example: rice, 2 ounces; slice of apple pie, 1/8 of a pie).
If you are currently taking megestrol, any corticosteroid, mirtazapine, metoclopramide, or dronabinol and you change your dose while on study, you will be taken off study. Also, if you were not on them before but you start taking any of the above listed drugs while on this study, you will be taken off study.
This is an investigational study. About 32 people will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Anorexia, Weight Loss, Cachexia
- Being tested
- Haelan
- Keywords
- Solid Tumors, Cancer-Associated Anorexia, Weight Loss, Haelan, Fermented Soy Product, Nutrition, Cachexia
- Medical subject headings
- Anorexia, Weight Loss, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaelanDrug
Also called Fermented Soy Supplement
4 oz orally twice daily for 8 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Fermented Soy Supplement | Other | 4 oz Haelan orally twice daily for 8 weeks Receives: Drug: Haelan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)
Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
Measured: Baseline and Week 4 +/- 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Study terminated due to low recruitment.
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 AnorexiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Haelan Products, Inc.
- Responsible party
- Sponsor
- Investigators
- Ying Guo, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558558
- Sponsor's protocol ID
- 2005-0370
- Status last verified
- Sep 2011
- First submitted
- 13 Nov 2007
- Last updated
- 13 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Examining the Role of Fermented Soy Beverage for Improving Cancer-Associated Anorexia and Cachexia
- ClinicalTrials.gov ID
- NCT00558558
- Acronym / sponsor ID
- 2005-0370
- Conditions
- Anorexia, Weight Loss, Cachexia
- Keywords
- Solid Tumors, Cancer-Associated Anorexia, Weight Loss, Haelan, Fermented Soy Product, Nutrition, Cachexia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low recruitment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Haelan Products, Inc.
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Posted 12 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary:
- To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
- To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
- To determine if treatment with Haelan can increase patient's calorie intake, albumin, pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence analysis), and weight at week 4+/- 5 days.
- To determine if treatment with Haelan can decrease patient's Functional assessment of anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days.
- To assess the feasibility of accrual, and adherence to the Haelan consumption.
Secondary:
- Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients.
- Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with primary outcome in these patients.
- To determine if treatment with Haelan can increase patient's functional status at week 4+/- 5 days.
Detailed description
Individuals who have cancer-related malnutrition have also been found to have a higher risk of complications and are less able to tolerate the side effects of conventional therapies such as chemotherapy, radiation, and surgery.
Haelan is a soy-based liquid (beverage). It contains large amount of isoflavones. Isoflavones inhibit "nuclear factor-kappa B," which may lead to prevention of weight loss.
If you are eligible to take part in this study, you will then be given 2 fluid ounces of Haelan, as a taste test. If you are not able to tolerate the taste of Haelan, you will not be eligible for this study.
If you are able to pass the taste test and you are a woman who is able to have children, you will be asked to have a pregnancy test 24 hours prior to registration to Part B. Then only if you test negative for the pregnancy test will you be considered eligible for this study. If you are a female patient and refuse to practice accepted methods of contraceptives during the study, you will not be eligible for this study.
If you are still eligible for this study, you will have about 6 teaspoons of blood drawn, for baseline routine tests. Your height and weight will be measured. You will be instructed by a research nurse to recall your one day food intake before starting treatment. You will be asked about any medications you are taking (especially any appetite stimulants, such as megestrol, corticosteroid, and marinol), including the dose and when you take them. If you are able to tolerate the taste of Haelan, you will be instructed to drink 4 ounces of Haelan soy beverage 2 times a day, on an empty stomach, for 8 weeks. You may add water, stevia, honey or artificial sweeteners into Haelan prior to drinking it to improve the tolerance of Haelan. If you are unable to tolerate 4 ounces of Haelan twice a day after 2 attempts, the dose will be reduced to 2 ounces twice a day. If you are still not able to tolerate it after 2 attempts, the dose will be reduced again to 1 ounce twice a day. If you still cannot tolerate drinking this Haelan dose after 2 more attempts, the dose will be reduced again to 1 ounce daily. If you cannot tolerate at least 1 ounce a day for 5 consecutive days, you will be taken off this study. If you vomit within half hour of taking the Haelan, you should try at least 2 more times to drink at least 1 ounce of Haelan on the same day. If unsuccessful, please record that you were not able to take the Haelan on that day. If you cannot tolerate at least 1 ounce of Haelan a day for 5 days in a row, you will be taken off this study.
If you are able to pass the taste test and if you are a female with child-bearing potential you will be asked to have a pregnancy test 24 hours prior to registration to Part B .
You will be asked to write down how many ounces of Haelan you are able to drink at each dose and each day, in a study-drug diary. You will be asked to write down the side effect of Haelan daily.
You will be asked to write down the side effect of Haelan daily. You will have about 6 teaspoons of blood drawn for routine clinical tests, for protein level and kidney function at Week 4 +/- 5 days. You will also be asked to complete 3 questionnaires that have questions about any appetite, nausea, and fatigue you experience and your overall sense of well being. These questionnaires will take about 15 minutes to complete. You will be given several tests to measure your weight, skin-fold thickness and body composition. You will be given 2 functional tests, which involves timing how long it takes for you to get up from a chair to walk and timing how long it takes for you to walk 50 feet at your fastest speed. These tests will take about 30 minutes to complete. The questionnaires, measurement of your weight, skin-fold thickness and body composition, and functional tests will be done before treatment starts and on a visit day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days.
You will also be instructed by a research nurse to record your food intake, for one day in day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days.
During this study, you will have several tests performed to check for safety and effectiveness. Every 2 weeks, you will be asked if you are experiencing any side effects, either related or not related to the treatment. You will be asked about any medications you are taking, including the dose levels and when you take them.
You will be asked to bring the Haelan intake diary back to clinic on the study visits between day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days, so the study staff can record how many ounces of Haelan you have taken every day.
At the end of Haelan soy beverage treatment (week 8 +/- 5 days), you will be asked to return to the clinic for a end-of-treatment visit. You will have blood drawn (about 6 teaspoons) for routine clinic tests to detect for protein level and kidney function. Your study-drug diary will be checked, and you will again be given the questionnaires. Measurement of your weight, skin-fold thickness and body composition, and functional tests will be given. You will be asked about any medications you are taking, including the dose levels and when you take them. You will also be asked to provide the research nurse with the record of one day food intake at 8 weeks +/- 5 days. The one day food intake record should be finished before coming in for your clinic visit, as long as it is the recording of the 8th week food intake. However, if the 8th-week clinic visit is on the first day of the 8th week, you can continue to record your food intake after the visit, and then return it to the research nurse at a later time. For this record, you need to write down what type of food you eat, and the estimated portion (for example: rice, 2 ounces; slice of apple pie, 1/8 of a pie).
If you are currently taking megestrol, any corticosteroid, mirtazapine, metoclopramide, or dronabinol and you change your dose while on study, you will be taken off study. Also, if you were not on them before but you start taking any of the above listed drugs while on this study, you will be taken off study.
This is an investigational study. About 32 people will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fermented Soy Supplement | Other | Drug: Haelan4 oz Haelan orally twice daily for 8 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Anorexia (defined as > 30mm on a visual analog scale [VAS] of 0 to 100mm)
- Weight loss (defined as weight loss > 5% within last 6 months)
- Normal cognition (per treating physician's opinion)
- Written informed consent
- Advanced solid tumor (defined as locally recurrent or metastatic disease)
Key exclusion criteria (10 listed)
- Evidence of ascites (per treating physician's opinion).
- Receiving supplementary tube feedings or parenteral nutrition
- Known mechanical obstruction of the alimentary tract, or intractable vomiting
- Add or change dose of the following medication within 2 weeks prior to this trial or during this trial: megestrol, corticosteroid, mirtazapine, metoclopramide and dronabinol, with the exception of pre-medication for chemotherapy (10-20 mg Decadron intavenous (IV) once and/or Reglan 10 mg IV x1 prior to chemotherapy).
- Allergic to soy.
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 |
|---|---|---|
| HaelanAlso: Fermented Soy Supplement4 oz orally twice daily for 8 Weeks | Drug | Fermented Soy Supplement |
Primary outcome
Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)
Time frame: Baseline and Week 4 +/- 5 days
Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Ying Guo, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Haelan in people with Anorexia and Weight Loss, run by M.D. Anderson Cancer Center 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 May 2016. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Oct 2011). 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?
Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product) (time frame: Baseline and Week 4 +/- 5 days). 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 May 2016.