Status:
COMPLETED
Flaxseed for the Treatment of Hot Flashes
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Conditions:
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its capacity to safely an...
Eligibility Criteria
Inclusion
- Inclusionary Criteria:
- Age greater than or equal to 18 years
- Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer.
- Bothersome hot flashes (defined by occurenece of greater than or equal to 14 times per week and of sufficient severity to make the patient desire therapeutic intervention).
- Presence of hot flashes for greater than or equal to 1 month prior to study entry.
- Life expectancy greater than or equal to 6 months.
- ECOG Performance Status (PS) 0 or 1 (see Appendix VIII)
- Exclusionary Criteria/Contraindications
- Any of the following current (less than or equal to 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but patient must have been on a constant dose for greater than or equal to 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a grocery store are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency)
- History of allergic or other adverse reaction to flaxseed, wheat, nuts, lactose, and/or certain spices
- Current or planned use of other agents for treating hot flashes (except stable dose of vitamine E or antidepressants are allowed as long as they wre started \>30 days prior to study initiation and are to be continued through the study period).
- Diabetes (as flaxseed can lower blood glucose levels and might have additive effects when used with antidiabetic drugs).
- Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture.
- Any of the following: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception
- Current use of anticoagulants including aspirin, clopidogrel (Plavix), ticlopidine (Ticlic), and coumadin (1 mg of dialy coumadin is allowed for central line patency).
- Diagnosis of/problems with von Willebrand's disease or other bleeding disorders.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00275704
Start Date
May 1 2005
Last Update
June 10 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905