Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer

NCT00794989 | Terminated DMC

• 3 other identifiers: I 81906RPCI-I-8190611-0575
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer. PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.

Conditions

Breast Cancer; Precancerous Condition

Keywords

breast cancer; atypical ductal breast hyperplasia; lobular breast carcinoma in situ; ductal breast carcinoma in situ; breast cancer prevention; high risk breast cancer

Outcome Measures

Primary Outcomes (1)

• Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months

  6 months

Secondary Outcomes (1)

• Tolerability and compliance

  6 months

Study Arms (2)

Arm 1: Intervention

EXPERIMENTAL

Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.

Dietary Supplement: Ground Flaxseed

Arm 2: Observational

OTHER

Patients do not receive ground flaxseed.

Other: No Intervention

Interventions

Ground Flaxseed DIETARY_SUPPLEMENT

Given orally

Arm 1: Intervention

No Intervention OTHER

Participants randomized to Arm 2 do not receive any intervention

Arm 2: Observational

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

* Patients enrolled in must meet ≥ 1 of the following criteria: * History of unilateral or bilateral atypical ductal hyperplasia with or without family history * History of atypical lobular hyperplasia or lobular carcinoma in situ with or without family history * History of ductal carcinoma in situ * Prior stage I breast cancer allowed provided it was adequately treated and therapy was completed ≥ 1 year ago * Lifetime risk for developing breast cancer \> 20% (based on Gail or Claus model) * No abnormal mammogram requiring short-term follow-up within the past 6 months * No severe atypia or carcinoma cells on RPRNA PATIENT CHARACTERISTICS: * Premenopausal * ECOG performance status 0-1 * Patients enrolled must meet the following criteria: * No peri- or postmenopausal status as determined by estradiol levels \< 20 ng/dL and FSH levels \> 45 ng/dL * No thrombocytopenia (defined as platelet count \< 50,000/mm\^3) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception consistently * No other prior malignancy allowed except for the following: * Basal cell or squamous cell carcinoma * In situ cervical cancer * No history of any of the following conditions within the past 5 years: * Crohn disease * Ulcerative colitis * Inflammatory bowel disease * Irritable bowel syndrome * Celiac sprue * Malabsorption syndrome * Diverticulitis * Diverticulosis * No allergy to flaxseed, other seeds or nuts, or wheat PRIOR CONCURRENT THERAPY: * Patients enrolled in part 1 must meet the following criteria: * No prior breast implants or tram-flap reconstruction * Breast reduction allowed * No prior neoadjuvant chemotherapy or other chemotherapy within the past year * No prior neoadjuvant hormonal therapy * No prior whole radiation to the contralateral breast undergoing random periareolar fine needle aspiration (RPFNA) * No concurrent coumadin or other chronic anticoagulants (even if they are held for surgery) * Patients enrolled in part 2 must meet the following criteria: * More than 1 year since prior chemotherapy and adjuvant hormonal therapy for breast cancer * No concurrent chemotherapy for breast cancer * At least 1 month since prior and no concurrent treatment with corticosteroid * At least 2 weeks since prior and no concurrent use of antibiotics * At least 2 weeks * No history of chest wall irradiation * No presence of breast implants * No prior or concurrent tamoxifen within the past 90 days * No chronic/concurrent medications that inhibit platelet function, including any of the following: * Aspirin * Non-steroidal anti-inflammatory drugs (i.e., Aleve®, Motrin®, ibuprofen) * Coumadin * Heparin * Low molecular weight heparin * Anti-platelet agents * No prior short-term use of platelet inhibitors ≥ 7 days prior to RPFNA * No concurrent ingestion of the following: * Pumpkin seeds * Sesame seeds * Fish oil supplements * At least 30 days since prior and no concurrent flaxseed supplements, fish oil, or flaxseed oil * No concurrent treatment for another malignancy

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (2)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Roswell Cancer Park Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Precancerous Conditions; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

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

Study Officials

• Swati Kulkarni, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

US (2)