Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- Postmenopausal as defined by 1 of the following*:

- Absence of a period in the past 12 months

- Bilateral oophorectomy

- 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

- 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

PRIOR CONCURRENT THERAPY:

- 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)