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Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes

Phase 2
18 Years
Not Enrolling
Hot Flashes

Thank you

Trial Information

Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes

Inclusion Criteria

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if flaxseed will lower the number and severity of hot flashes

Principal Investigator

Sandhya Pruthi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Hot Flashes
  • Hot Flashes



Mayo Clinic Rochester, Minnesota  55905