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
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hot Flashes Menopausal Symptoms Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: flaxseed Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 [ Designated as safety issue: No ]
- Toxicity as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Mood [ Designated as safety issue: No ]
- General menopausal symptoms [ Designated as safety issue: No ]
- Hot flash-related daily interference on activities [ Designated as safety issue: No ]
| Estimated Enrollment: | 210 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily.
|
Dietary Supplement: flaxseed
Given orally
|
|
Placebo Comparator: Arm II
Patients receive oral placebo bar once daily.
|
Other: placebo
Given orally
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Show 107 Study Locations| Study Chair: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00956813 History of Changes |
| Other Study ID Numbers: | CDR0000644811, NCCTG-N08C7 |
| Study First Received: | August 8, 2009 |
| Last Updated: | November 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
menopausal symptoms hot flashes breast cancer unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013