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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02314156` - Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy	Phase 2
Completed	`NCT01874184` - Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer	N/A
Active, not recruiting	`NCT01905046` - Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer	Phase 3
Completed	`NCT01869764` - Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer	Phase 2
Completed	`NCT02587663` - Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI	N/A
Active, not recruiting	`NCT04537312` - Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)	N/A
Active, not recruiting	`NCT01245712` - Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer	Phase 2
Recruiting	`NCT02993159` - Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast	Phase 2
Completed	`NCT01753908` - Broccoli Sprout Extract in Treating Patients With Breast Cancer	Early Phase 1
Terminated	`NCT02023008` - Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy	N/A
Completed	`NCT01849250` - Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors	Phase 2
Terminated	`NCT01754519` - Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery	Phase 2
Completed	`NCT01819233` - Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy	N/A
Active, not recruiting	`NCT03077841` - Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer	Phase 2/Phase 3
Active, not recruiting	`NCT02352883` - MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ	N/A
Recruiting	`NCT03909282` - Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma	N/A
Completed	`NCT01723943` - Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients	N/A
Completed	`NCT00637481` - A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer	Phase 1
Completed	`NCT01975363` - Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer	N/A
Active, not recruiting	`NCT03391388` - 3D-CRT, Proton, or Brachytherapy APBI in Treating Patients With Invasive and Non-invasive Breast Cancer	Phase 2