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
Condition: Breast Cancer; Hot Flashes; Menopausal Symptoms; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Breast Neoplasms; Hot Flashes
Intervention: flaxseed; placebo
Intervention description: Given orally; Given orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 210.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: menopausal symptoms; hot flashes; breast cancer; unspecified adult solid tumor, protocol specific

Summary:

      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.
    

Eligibility criteria:

        -  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)