Breast Cancer Clinical Trial
Official title:
Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes
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.
OBJECTIVES:
- To evaluate the efficacy of flaxseed on hot flash scores in women with a history of
breast cancer or other cancer or in women who do not wish to take estrogen therapy for
fear of increased risk of breast cancer as measured by a daily prospective hot flash
diary.
- To evaluate the side effect profile of flaxseed in this population.
- To evaluate the effects of flaxseed on mood (per the Profile of Mood States) and
broader menopausal symptoms (per the MENQOL), daily interference from hot flashes (per
the HFRDIS), and perception of benefit (per Global Impression of Change).
OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); treatment
with tamoxifen citrate, selective estrogen receptor modulators, or aromatase inhibitors (yes
vs no); duration of hot flashes (≤ 9 months vs > 9 months); and daily frequency of hot
flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral flaxseed in the form of a bar similar to a granola bar
once daily.
- Arm II: Patients receive oral placebo bar once daily. In both arms, treatment continues
for 6-12 weeks. Patients in arm II may crossover to receive treatment as in arm I after
6 weeks.
Patients complete questionnaires (Hot Flash Diary, Side Effect Experience Questionnaire,
Profile of Mood States, Hot Flash Related Daily Interference Scale, and Menopause Specific
Quality of Life) at baseline and periodically during treatment. Patients are contacted by
telephone at the end of weeks 2, 4, 5, and 7 to assess product tolerability, document
compliance, encourage completion of questionnaires, and address problems.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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