Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

NCT ID: NCT02150525

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I (oral omega-3 fatty acid)

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.

Group Type: EXPERIMENTAL

omega-3 fatty acid

Intervention Type: DIETARY_SUPPLEMENT

Given PO (by mouth) daily

Questionnaire administration

Intervention Type: 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 II (placebo)

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given PO(by mouth)daily

Questionnaire administration

Intervention Type: 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).

Interventions

omega-3 fatty acid

Given PO (by mouth) daily

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given PO(by mouth)daily

Intervention Type: OTHER

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

fish oil; n-3 fatty acid; O3FA; PUFAs; PLCB

Eligibility Criteria

Inclusion Criteria

• 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
• Hemoglobin > 10 g/dL
• Hematocrit > 30%
• White blood count > 3.5 K/uL
• Platelet count > 100,000/mm^3
• Fasting serum glucose < 115 mg/dL
• Total bilirubin < 1.6 mg/dL
• Transaminases alanine aminotransferase(ALT)and aspartate aminotransferase (AST)< 1.5 x ULN (upper limit of normal)

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanne Lester, PhD, CRNP

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Medical Center, Comprehensive Breast Center

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2013-00068

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-09145

Identifier Type: -

Identifier Source: org_study_id