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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00031720
Other study ID # CALGB-79805
Secondary ID U10CA076001CALGB
Status Completed
Phase Phase 2
First received March 8, 2002
Last updated July 12, 2016
Start date March 2002
Est. completion date November 2013

Study information

Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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 breast disease such as ductal hyperplasia or breast cancer.


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:

1. 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

2. 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:

1. 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

2. 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

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date November 2013
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Eligibility Criteria:

1. 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.

2. Current daily tamoxifen use. Any planned surgery, adjuvant chemotherapy or radiation must have been completed.

3. 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.

4. Postmenopausal status: surgical menopause, no menses for = 1 year or postmenopausal FSH levels.

5. 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.

6. 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.

7. No concurrent systemic hormone replacement therapy or use of vaginal estrogen creams. Use of the estradiol releasing vaginal ring (Estring®) is allowed.

8. No history of soy or milk intolerance

9. CALGB performance status 0-2

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
soy protein
Given orally
isoflavones
Given orally
Drug:
Tamoxifen

Other:
Placebo
Oral

Locations

Country Name City State
United States Elkhart General Hospital Elkhart Indiana
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Kingsbury Center for Cancer Care at Cheshire Medical Center Keene New Hampshire
United States Kinston Medical Specialists Kinston North Carolina
United States Howard Community Hospital Kokomo Indiana
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst North Carolina
United States Center for Cancer Care at OSF Saint Anthony Medical Center Rockford Illinois
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States Lakeland Regional Cancer Care Center - St. Joseph St. Joseph Michigan
United States Commonwealth Hematology-Oncology, PC - Worcester Worcester Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI), Protein Technologies International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of daily hot flushes at 3 months from baseline Up to 3 months No
Primary Change in hot-flush score at 3 months from baseline Up to 3 months No
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