CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 210 enrolled
Drug / intervention
flaxseed +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00956813
NCT00956813Phase 3Completed
CompareCT.gov

Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes

Alliance for Clinical Trials in Oncology·interventional·Posted Aug 11, 2009·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating flaxseed and placebo for Breast Cancer and 3 related conditions. Completed, enrolled 210 participants across 107 sites.

Detailed Summary

RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and quality of life in postmenopausal women not receiving estrogen therapy. PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in treating postmenopausal women with hot flashes who have a history of breast cancer or other cancer or who do not wish to take estrogen therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Hot Flashes, Menopausal Symptoms, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2010
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.9 years ago

Interventions

flaxseeddietary

Given orally

placeboother

Given orally