NCT02150525

Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ductal Breast Carcinoma in Situ
• Breast Cancer, Stage I
• Breast Cancer, Stage II
• Breast Cancer, Stage III

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	omega-3 fatty acid	Given PO (by mouth) daily
OTHER	placebo	Given PO(by mouth)daily
BEHAVIORAL	Questionnaire administration	Measures of self-reported outcomes: Self-reported symptoms will be documented with the Urogenital Atrophy Questionnaire (UAQ), Menopausal Rating Scale (MRS), Female Sexual Function Index (FSFI), Center for Epidemiological Studies Short Depression Scale (CES-D 10), and Brief Pain Inventory (BPI).

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2014-05-30
• Last updated: 2018-08-09

Locations

1 site across 1 country: United States