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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

Sponsored by Alliance for Clinical Trials in Oncology

About this trial

Last updated 9 years ago

Study ID

N08C7

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18+ Years
Female

Trial Timing

Ended 13 years ago

What is this trial about?

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.

What are the Participation Requirements?

* 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)