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Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

NCT02150525 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-08-09

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Joanne Lester, PhD, CRNP · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150525 on ClinicalTrials.gov