NCT00275704

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

January 10, 2006

Last Update Submit

June 9, 2011

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (5)

  • 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.

Interventions

FlaxseedDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Sandhya Pruthi, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

May 1, 2005

Primary Completion

June 1, 2006

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

US(1)