Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

NCT02150525 | Completed Phase 2 DMC

• 2 other identifiers: OSU-09145NCI-2013-00068
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast cancer; vaginal dryness; dyspareunia; genital irritation

Outcome Measures

Primary Outcomes (1)

• Explore the ability of oral omega 3 fatty acids to improve symptoms of atrophic vaginitis as self-reported by postmenopausal breast cancer survivors that took omega 3 vs. those survivors who did not take omega 3.

  Self-reported measures included the Urogenital Atrophy Questionnaire, Brief Pain Inventory, Menopause Rating Scale, and Female Sexual Function Index. These measures were compared in women assigned to omega 3 fatty acids vs. women assigned to placebo of dietary supplement.

  From baseline to 3 and 6 months

Secondary Outcomes (4)

• Explore the ability of oral omega 3 fatty acids to decrease inflammation related to atrophic vaginitis in postmenopausal breast cancer survivors who took omega 3 fatty acids as compared to those survivors who did not take omega 3.

  From baseline to 3 and 6 months

• Determine level of omega 3 uptake in those who took omega 3 vs. those who took placebo of dietary supplement by using tested serum levels of omega 3 fatty acids in all participants.

  From baseline to 3 and 6 months

• Measure if effects exist from omega 3 fatty acids by using tested serum hormone levels in all participants.

  From baseline to 3 and 6 months

• Determine if an effect existed in women that took omega 3 fatty acids by using tested cytokine levels in all participants.

  From baseline to 3 and 6 months

Study Arms (2)

Arm I (oral omega-3 fatty acid)

EXPERIMENTAL

Patients received 3.5g oral omega-3 fatty acid daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals.

Dietary Supplement: omega-3 fatty acid; Behavioral: Questionnaire administration

Arm II (placebo)

PLACEBO COMPARATOR

Patients received equivalent, matched oral placebo (seven capsules) daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals.

Other: placebo; Behavioral: Questionnaire administration

Interventions

omega-3 fatty acid DIETARY_SUPPLEMENT

Given PO (by mouth) daily

Also known as: fish oil, n-3 fatty acid, O3FA, PUFAs

Arm I (oral omega-3 fatty acid)

placebo OTHER

Given PO(by mouth)daily

Also known as: PLCB

Arm II (placebo)

Questionnaire administration BEHAVIORAL

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).

Arm I (oral omega-3 fatty acid); Arm II (placebo)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman with a history of breast cancer, stage 0, I, II, or III
• At least 12 months from definitive surgical procedure (i.e. lumpectomy or mastectomy)
• At least 3 months from completion of chemotherapy
• Postmenopausal, defined as no menstrual cycle for 12 consecutive months, or surgical menopause
• Have one or more stated symptoms of atrophic vaginitis, such as vaginal dryness, genital irritation/itching, genital pain, and/or dyspareunia
• No current use of estrogen replacement therapy
• If recent use of estrogen replacement therapy, off at least three months
• No current use of estradiol-releasing vaginal ring or estradiol vaginal tablets; if recent use of these products, off at least 3 consecutive months
• No evidence of disease (NED), any cancer other than breast cancer
• No current use of oral omega 3 fatty acids or Vitamin E; if recent consistent use of these products, off at least six months; if sporadic use of these products, off at least 3 consecutive months
• May be taking oral anti-estrogens or aromatase inhibitors, and/or biologic therapy
• Must be willing to undergo venipuncture at 0, 3, and 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• No history of a bleeding tendency
• No history of uncontrolled hypertension, heart disease or stroke

You may not qualify if:

• Metastatic malignancy of any kind
• Ongoing chemotherapy or radiation therapy (ongoing hormonal therapy and/or biologic therapy are allowed)
• History of pelvic or genital radiation therapy
• Use of Coumadin or other anticoagulants
• Known, active pelvic, vaginal, or urinary tract infections
• Current use of hormone replacement therapy, either systemic or local
• Uncontrolled co-morbidities including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable hypertension
• Psychiatric illness/social situation that would limit adherence to study requirements
• Consistent use of omega-3 fatty acid concentrates or capsules within the 6 months prior to entry on the study
• Known sensitivity or allergy to fish oil or omega 3 fish products
• Pregnant or nursing women
• Subjects who cannot give an informed consent

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University Medical Center, Comprehensive Breast Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms; Dyspareunia

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• Joanne Lester, PhD, CRNP

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: May 30, 2014
• Study Start: August 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

US (1)