Clinical trial · Interventional
Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer
A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk
NCT00794989CI-TRIAL-00022485terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ground Flaxseed | Dietary Supplement | — | UNRESOLVED |
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Intervention
- description
- Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.
- interventionNames
- Dietary Supplement: Ground Flaxseed
- type
- OTHER
- label
- Arm 2: Observational
- description
- Patients do not receive ground flaxseed.
- interventionNames
- Other: No Intervention
Primary outcomes (1)
- measure
- Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 50 Years
Show eligibility criteria text
* 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 malignancyReferences
Publications (0)
Data not yet available
No reference posted for this study.