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
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.
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: flaxseed
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes|
- Hot flash score at week 7 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
- Toxicity as measured by CTCAE v3.0 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: Yes ]
- Change of mood as measured by the POMS [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
- Change of menopause specific quality of life as measured by the MENQOL [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
- Change of daily interference as measured by the HFRDIS [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily.
Dietary Supplement: flaxseed
Placebo Comparator: Arm II
Patients receive oral placebo bar once daily.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956813
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|Study Chair:||Debra Barton, RN, PhD, AOCN, FAAN||Mayo Clinic|