Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Status Completed

Clinical Trial Summary

This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To examine the ability of oral omega-3 fatty acids to improve symptoms of atrophic vaginitis as reported by postmenopausal breast cancer survivors as compared to survivors not taking omega 3.

II.To examine the ability of oral omega-3 fatty acids to decrease inflammation related to atrophic vaginitis in postmenopausal breast cancer survivors as compared to survivors not taking omega 3.

III. To examine the ability of oral omega-3 fatty acids to uptake systemically and to validate adherence; these measures will be compared to demographic data including body mass index to observe if differences exist in postmenopausal breast cancer survivors vs. those not taking omega 3.

IV. To examine the effect of oral omega 3 fatty acids as compared to placebo of dietary supplement on serum female hormone levels in postmenopausal breast cancer survivors.

V. To examine cytokine levels in women taking oral omega 3 fatty acids as compared to women not taking omega 3 to determine effect.

OUTLINE: Patients were randomized to 1 of 2 treatment arms.

ARM I: Patients received 3.5g omega-3 fatty acid orally (PO) daily for 6 months.

ARM II: Patients received placebo of dietary supplement (7 capsules) PO daily for 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02150525
Study type	Interventional
Source	Ohio State University Comprehensive Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	August 2010
Completion date	January 2013

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