Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease

NCT00031720 | Completed Phase 2 DMC

• 4 other identifiers: CALGB-79805U10CA076001NCI-P02-0206CDR0000069219
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 14

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Change in number of daily hot flushes at 3 months from baseline

  Up to 3 months

• Change in hot-flush score at 3 months from baseline

  Up to 3 months

Study Arms (2)

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.

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.

Drug: Tamoxifen; Other: Placebo

Interventions

soy protein DIETARY_SUPPLEMENT

Given orally

Arm I

isoflavones DIETARY_SUPPLEMENT

Given orally

Arm I

Tamoxifen DRUG

Arm I; Arm II

Placebo OTHER

Oral

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• Protein Technologies International: collaborator

Study Sites (14)

Center for Cancer Care at OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Commonwealth Hematology-Oncology, PC - Worcester

Worcester, Massachusetts, 01605, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, 03431, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Soybean Proteins; Isoflavones; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gini F. Fleming, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: April 1, 2006
• Study Completion: November 1, 2013
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (14)