- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00275704
Flaxseed for the Treatment of Hot Flashes
June 9, 2011 updated by: Mayo Clinic
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.
Study Overview
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandhya Pruthi, M.D., Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
January 10, 2006
First Submitted That Met QC Criteria
January 10, 2006
First Posted (Estimate)
January 12, 2006
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC04C9 (Other Identifier: Mayo Clinic Cancer Center)
- 247-05 (Other Identifier: Mayo Clinic IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hot Flashes
-
Mitsubishi Tanabe Pharma America Inc.CompletedMenopause Hot FlashesUnited States
-
University of California, San FranciscoCompleted
-
AmgenCompleted
-
University of California, San FranciscoCompleted
-
Alison Huang, MDNational Institute on Aging (NIA)Completed
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedTreatment of Menopausal Hot FlashesUnited States
-
Donesta BioscienceSynteractHCRCompleted
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)CompletedHot Flashes | Hot FlushesUnited States
-
University of PennsylvaniaForest LaboratoriesCompleted
-
National Institutes of Health Clinical Center (CC)National Cancer Institute (NCI)CompletedFever, Sweats, and Hot FlashesUnited States
Clinical Trials on Flaxseed
-
University of GuadalajaraHospital Civil de GuadalajaraUnknownMetabolic Syndrome | Nutritional and Metabolic DiseasesMexico
-
Universidade Federal do Rio de JaneiroConselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro...CompletedOverweight | Obese | Adult WomenBrazil
-
National Nutrition and Food Technology InstituteUnknownMetabolic SyndromeIran, Islamic Republic of
-
Universidad Miguel Hernandez de ElcheInstituto de Salud Carlos IIICompleted
-
University of Colorado, Colorado SpringsCompletedPreDiabetesUnited States
-
University of PennsylvaniaCompletedInflammation | Cystic Fibrosis | Oxidative StressUnited States
-
Wolfson Medical CenterTel Aviv District of the Health OfficeUnknown
-
St. Boniface HospitalAgriculture and Agri-Food CanadaRecruitingHealth Claim ImplementationCanada
-
Colorado State UniversityActive, not recruitingMenopauseUnited States