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Phase 3 N=210 Randomized Double-blind Supportive Care

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

Breast Cancer · Hot Flashes · Menopausal Symptoms · Unspecified Adult Solid Tumor, Protocol Specific

Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary. — -4.9; -3.5 units on a scale — p=0.29

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
flaxseed (Dietary_supplement); placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Alliance for Clinical Trials in Oncology
Primary completion
Oct 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.
-4.9; -3.5 0.29
SECONDARY
Toxicity as Measured by CTCAE v3.0
0; 1; 0; 0
SECONDARY
Change of Mood as Measured by the Profile of Mood States (POMS)
6.6; 5.7 0.93
SECONDARY
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
22.5; 18.7; 9.9; 11.1; 9.3; 11.8 0.19
SECONDARY
Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
13.9; 9.8 0.089

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00956813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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