Clinical trial · Interventional
Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy
Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes
NCT00956813CI-TRIAL-00026746completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and quality of life in postmenopausal women not receiving estrogen therapy. PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in treating postmenopausal women with hot flashes who have a history of breast cancer or other cancer or who do not wish to take estrogen therapy.
Conditions
Conditions (4)
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 |
| Hot Flashes | — | UNRESOLVED | — |
| Menopausal Symptoms | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flaxseed | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily.
- interventionNames
- Dietary Supplement: flaxseed
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo bar once daily.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.
- timeFrame
- Baseline and 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
* Bothersome hot flashes, defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention * Presence of hot flashes for ≥ 1 month * Meets 1 of the following criteria: * History of breast cancer or other cancer (currently without malignant disease) * No history of breast cancer and wishes to avoid estrogen due to a perceived increased risk of breast cancer * Hormone receptor status not specified * Postmenopausal as defined by 1 of the following\*: NOTE: \*Women with ≥ 1 ovary but without a uterus should be deemed postmenopausal by either age \> 55 OR a combination of estrogen within a postmenopausal range (per local lab) and follicle-stimulating hormone \> 40 mIU/mL * Absence of a period in the past 12 months * Bilateral oophorectomy * ECOG performance status 0-1 * Life expectancy ≥ 6 months * Able to complete questionnaire(s) alone or with assistance * No diabetes requiring oral or injectable antihyperglycemics * No hypotension * No history of allergic or other adverse reaction to flaxseed * No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal condition where the patient should not consume and/or has an intolerance/allergies to seeds or nuts * At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents * Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for ≥ 4 weeks and is not expected to stop the medication during study treatment • At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind * Trastuzumab allowed * No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies * No concurrent (≤ 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal) * Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is ≤ 800 IU/day, it was started \> 30 days before study initiation, and is to be continued through study period * Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible • No concurrent anticoagulants or anti-platelets (1 mg of Coumadin for central line patency allowed) * Aspirin allowed (≤ 81 mg) * No concurrent anti-hypertensives * No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk)
References
Publications (2)
- RESULTPruthi S, Qin R, Terstreip SA, Liu H, Loprinzi CL, Shah TR, Tucker KF, Dakhil SR, Bury MJ, Carolla RL, Steen PD, Vuky J, Barton DL. A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North Central Cancer Treatment Group N08C7. Menopause. 2012 Jan;19(1):48-53. doi: 10.1097/gme.0b013e318223b021. PMID 21900849
- RESULTPruthi S, Qin R, Terstriep SA, et al.: The evaluation of flaxseed for hot flashes: results of a randomized, controlled trial, NCCTG study N08C7. [Abstract] J Clin Oncol 29 (Suppl 15): A-CRA9015, 2011.