Status:
COMPLETED
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
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 p...
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 increa...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00956813
Start Date
October 1 2009
End Date
May 1 2013
Last Update
April 4 2017
Active Locations (107)
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1
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
2
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
3
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
4
St. Anthony Central Hospital
Denver, Colorado, United States, 80204