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Flaxseed for the Treatment of Hot Flashes

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Flaxseed
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2006
Last Updated
June 9, 2011
Sponsor
Mayo Clinic
Collaborators
Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00275704
Brief Title
Flaxseed for the Treatment of Hot Flashes
Official Title
Phase II Evaluation of Flaxseed for the Treatment of Hot Flashes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Flaxseed
Primary Outcome Measure Information:
Title
Determine if flaxseed will lower the number and severity of hot flashes
Title
Determine if there are any side effects from taking flaxseed for hot flashes
Title
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.
Title
Evaluate the toxicity of flaxseed in this study population.
Title
Evaluate the effect of flaxseed on quality-of-life measures.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandhya Pruthi, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Flaxseed for the Treatment of Hot Flashes

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