Flaxseed for the Treatment of Hot Flashes

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.