Ovarian CancerNCT00293293
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
A study testing healing touch, massage therapy and hypnosis in people with Ovarian Cancer and Peritoneal Primary Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Primary Cancer, Fallopian Tube Cancer
- What is being tested?
- healing touch, massage therapy and hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jan 2010
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
- Patients must have signed an informed consent
Who cannot join
- Previous cancer other than skin cancer
- Previous chemotherapy experience
- Active substance abuse
- Schizophrenia
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.
PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.
Secondary
- Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes with each course of chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4.
Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment.
After completion of study treatment, patients are followed at 6 months.
- Being tested
- healing touch, massage therapy, hypnosis, Standard chemotherapy
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healing touchOther
Also called energy-based therapy
The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.
massage therapyOther
Also called massage
Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.
hypnosisOther
Also called mind-body intervention procedure
Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.
Standard chemotherapyDrug
Also called Taxane, Platinum
Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy Alone | Active comparator | Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol. Receives: Drug: Standard chemotherapy |
| Standard Chemotherapy + CAM | Experimental | Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol. Receives: Other: healing touch; Other: massage therapy; Other: hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.
Measured: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).
Measured: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Secondary outcomes (13)
Number of Patients With Delays In Receiving Chemotherapy Alone
Number of patients who had to delay their chemotherapy treatments due to side effects.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Number of Patients With Delays In Receiving Chemotherapy Plus CAM
Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone
Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM
Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Anti-Emetic Dose Use After Chemotherapy Alone
Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Natural Killer Cell Count Levels Before Chemotherapy Alone
Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Natural Killer Cell Count Levels Before Chemotherapy and CAM
Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM
Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM
Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM
Determined from white blood cell counts collected during treatment phase of study; average applied.
Measured: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)
Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM
Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM
Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.
Measured: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startMay 2005
- Primary completionApr 2009
- Study completionJan 2010
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 Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Randy Shaver Cancer Research Fund
- Responsible party
- Sponsor
- Investigators
- Patricia L. Judson, MD, Study chair, Moffitt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293293
- Sponsor's protocol ID
- 2000NT790
- Other IDs
- UMN-WCC-30, 0012M77821
- Status last verified
- Dec 2017
- First submitted
- 16 Feb 2006
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
- ClinicalTrials.gov ID
- NCT00293293
- Acronym / sponsor ID
- 2000NT790
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Randy Shaver Cancer Research Fund
- Study start
- May 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 6 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.
PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.
Detailed description
OBJECTIVES:
Primary
- Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.
Secondary
- Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes with each course of chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4.
Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment.
After completion of study treatment, patients are followed at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy Alone | Active comparator | Drug: Standard chemotherapyPatients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol. |
| Standard Chemotherapy + CAM | Experimental | Other: healing touch, Other: massage therapy, Other: hypnosisPatients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
- Patients must have signed an informed consent
Key exclusion criteria (5 listed)
- Previous cancer other than skin cancer
- Previous chemotherapy experience
- Active substance abuse
- Schizophrenia
- Pregnant or lactating
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 |
|---|---|---|
| healing touchAlso: energy-based therapyThe practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing. | Other | Standard Chemotherapy + CAM |
| massage therapyAlso: massageStandard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level. | Other | Standard Chemotherapy + CAM |
| hypnosisAlso: mind-body intervention procedureSteps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time. | Other | Standard Chemotherapy + CAM |
| Standard chemotherapyAlso: Taxane, PlatinumPatients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study. | Drug | Chemotherapy Alone |
Primary outcome
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
Time frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
Time frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).
13 secondary outcomes
Number of Patients With Delays In Receiving Chemotherapy Alone
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Number of Patients With Delays In Receiving Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Anti-Emetic Dose Use After Chemotherapy Alone
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Natural Killer Cell Count Levels Before Chemotherapy Alone
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Average Natural Killer Cell Count Levels Before Chemotherapy and CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)
Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 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.
Patricia L. Judson, MD study chair
Moffitt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healing touch, massage therapy and hypnosis in people with Ovarian Cancer and Peritoneal Primary Cancer, run by Masonic Cancer Center, University of Minnesota 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 2 inclusion and 5 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 28 Dec 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2012). 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?
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) (time frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy). The study lists 2 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 28 Dec 2017.