Flaxseed for the Treatment of Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275704
First received: January 10, 2006
Last updated: June 9, 2011
Last verified: June 2011

January 10, 2006
June 9, 2011
May 2005
June 2006   (final data collection date for primary outcome measure)
  • Determine if flaxseed will lower the number and severity of hot flashes
  • Determine if there are any side effects from taking flaxseed for hot flashes
  • Evaluate the impact of flaxseed on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
  • Evaluate the toxicity of flaxseed in this study population.
  • Evaluate the effect of flaxseed on quality-of-life measures.
Same as current
Complete list of historical versions of study NCT00275704 on ClinicalTrials.gov Archive Site
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Flaxseed for the Treatment of Hot Flashes
Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes

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 and effectively treat hot flashes. Specifically, this study seeks to determine if flaxseed will lower the number and severity of hot flashes and if women experience any side effects from taking flaxseed for this purpose.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hot Flashes
Drug: Flaxseed
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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June 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275704
MC04C9, MC04C9, 247-05
Not Provided
Sandhya Pruthi, M.D., Mayo Clinic Cancer Center
Mayo Clinic
Susan G. Komen Breast Cancer Foundation
Principal Investigator: Sandhya Pruthi, M.D. Mayo Clinic
Mayo Clinic
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP