Breast CancerPhase 2NCT00031720
Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
A Phase 2 study testing soy protein, isoflavones and Tamoxifen in people with Breast Cancer and Hot Flashes, run by Alliance for Clinical Trials in Oncology at 14 sites in United States.
Trial summary
RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease. PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes, Hot Flushes
- What is being tested?
- soy protein, isoflavones and Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2002to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria:
- Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A.
- Current daily tamoxifen use. Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
- History of bothersome hot flushes: ≥ 7 hot flushes/day, sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.
- Postmenopausal status: surgical menopause, no menses for ≥ 1 year or postmenopausal FSH levels.
- No concurrent use of vitamin E, progestins (Megace® or others), clonidine, belladonna derivative or commercially available soy supplement preparations for treatment of hot flushes. Participants must have at least a 4-week washout period prior to day 1 of run-in if any of these have been used. Participants may be taking low doses of vitamin E that are part of a multivitamin.
- Concurrent use of anti-depressant, such as Paxil® , Prozac®, or Effexor® is allowed if the participant has been on a stable dose for more than a month and the purpose of the medication is for other than control of hot flushes. If SSRI's are used for hot flashes, they must be discontinued for 4 weeks prior to day 1 of run-in.
- No concurrent systemic hormone replacement therapy or use of vaginal estrogen creams. Use of the estradiol releasing vaginal ring (Estring®) is allowed.
- No history of soy or milk intolerance
- CALGB performance status 0-2
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Elkhart General Hospital
Elkhart, Indiana, 46515
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, 03431
Kinston Medical Specialists
Kinston, North Carolina, 28501
Howard Community Hospital
Kokomo, Indiana, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, 61108
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
Commonwealth Hematology-Oncology, PC - Worcester
Worcester, Massachusetts, 01605
About this study
Official title: Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease.
PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.
Read the detailed description
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to duration of hot flashes (less than 9 months vs 9 months or more) and frequency of hot flashes (7 to 9 per day vs more than 9 per day). For more information regarding the treatment regimens, please see the treatment arms section.
Primary objectives:
- To compare the effect of daily soy supplementation versus placebo on the daily number of hot flushes experienced by postmenopausal women taking tamoxifen measured at three months from baseline
- To compare the effect of daily soy supplementation versus placebo on hot flush severity as measured by the average daily hot flash score in this population of women measured at three months from baseline
Secondary objectives:
- To evaluate the effect of soy supplementation as compared to women randomized to placebo on quality of life as measured by the Medical Outcomes Study (MOS) sleep subscale, the Mental Health Inventory (MHI), the CES-D Short Form, the Menopause and Reproductive Health Questionnaire, and the General Quality of Life Form
- To measure the effect of soy supplementation as compared to women randomized to placebo on serum isoflavones, estradiol, SHBG, IGF1 and IGFBP3 levels as measures of hormonal change
- To estimate the effect of daily soy supplementation versus placebo on the time to first relief of hot flushes
A total of 112 patients accrued on this study. Patients were followed 6 months post-randomization.
- Conditions
- Breast Cancer, Hot Flashes, Hot Flushes
- Being tested
- soy protein, isoflavones, Tamoxifen, Placebo
- Keywords
- lobular breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, ductal breast carcinoma in situ, hot flashes
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy proteinDietary supplement
Given orally
isoflavonesDietary supplement
Given orally
TamoxifenDrug
PlaceboOther
Oral
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | All patients receive placebo for 7 days as part of the run-in period. Patients being treated with tamoxifen were randomized to treatment arm I and received 40 gm soy protein and 90 mg isoflavones daily for 12 weeks. Receives: Dietary Supplement: soy protein; Dietary Supplement: isoflavones; Drug: Tamoxifen |
| Arm II | Placebo comparator | All patients receive placebo for a 7 day run in period. Patients being treated with tamoxifen randomized to Arm II received placebo daily for 12 weeks. Receives: Drug: Tamoxifen; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of daily hot flushes at 3 months from baseline
Measured: Up to 3 months
Change in hot-flush score at 3 months from baseline
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- Primary completionApr 2006
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Protein Technologies International
- Responsible party
- Sponsor
- Investigators
- Gini F. Fleming, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031720
- Sponsor's protocol ID
- CALGB-79805
- Other IDs
- U10CA076001, CALGB-79805, NCI-P02-0206, CDR0000069219
- Status last verified
- Jul 2016
- First submitted
- 8 Mar 2002
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
- ClinicalTrials.gov ID
- NCT00031720
- Acronym / sponsor ID
- CALGB-79805
- Conditions
- Breast Cancer, Hot Flashes, Hot Flushes
- Keywords
- lobular breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, ductal breast carcinoma in situ, hot flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Protein Technologies International
- Study start
- Mar 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease.
PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.
Detailed description
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to duration of hot flashes (less than 9 months vs 9 months or more) and frequency of hot flashes (7 to 9 per day vs more than 9 per day). For more information regarding the treatment regimens, please see the treatment arms section.
Primary objectives:
- To compare the effect of daily soy supplementation versus placebo on the daily number of hot flushes experienced by postmenopausal women taking tamoxifen measured at three months from baseline
- To compare the effect of daily soy supplementation versus placebo on hot flush severity as measured by the average daily hot flash score in this population of women measured at three months from baseline
Secondary objectives:
- To evaluate the effect of soy supplementation as compared to women randomized to placebo on quality of life as measured by the Medical Outcomes Study (MOS) sleep subscale, the Mental Health Inventory (MHI), the CES-D Short Form, the Menopause and Reproductive Health Questionnaire, and the General Quality of Life Form
- To measure the effect of soy supplementation as compared to women randomized to placebo on serum isoflavones, estradiol, SHBG, IGF1 and IGFBP3 levels as measures of hormonal change
- To estimate the effect of daily soy supplementation versus placebo on the time to first relief of hot flushes
A total of 112 patients accrued on this study. Patients were followed 6 months post-randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: soy protein, Dietary Supplement: isoflavones, Drug: TamoxifenAll patients receive placebo for 7 days as part of the run-in period. Patients being treated with tamoxifen were randomized to treatment arm I and received 40 gm soy protein and 90 mg isoflavones daily for 12 weeks. |
| Arm II | Placebo comparator | Drug: Tamoxifen, Other: PlaceboAll patients receive placebo for a 7 day run in period. Patients being treated with tamoxifen randomized to Arm II received placebo daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| soy proteinGiven orally | Dietary supplement | Arm I |
| isoflavonesGiven orally | Dietary supplement | Arm I |
| Tamoxifen | Drug | Arm I, Arm II |
| PlaceboOral | Other | Arm II |
Primary outcome
Change in number of daily hot flushes at 3 months from baseline
Time frame: Up to 3 months
Change in hot-flush score at 3 months from baseline
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Gini F. Fleming, MD study chair
University of Chicago
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing soy protein, isoflavones and Tamoxifen in people with Breast Cancer and Hot Flashes, run by Alliance for Clinical Trials in Oncology at 14 sites 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?
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 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 number of daily hot flushes at 3 months from baseline (time frame: Up to 3 months). 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 13 Jul 2016.