Back to results

Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

omega-3 fatty acid

placebo

Questionnaire administration

About this trial

This is an interventional supportive care trial for Ductal Breast Carcinoma in Situ focused on measuring breast cancer, vaginal dryness, dyspareunia, genital irritation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The Ohio State University Medical Center, Comprehensive Breast Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (oral omega-3 fatty acid)

Arm II (placebo)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

This was measured by self-reported pain to touch during gynecological examination, self-reported vaginal dryness, pain, or irritation, wet prep results (presence or absence of yeast), pH, and parabasal layer that indicated a shift to less inflamed tissue, and gynecologic examination results.

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.

Tested serum levels to evaluate the level of omega 3 fatty acids in women assigned to omega 3 vs. women assigned to placebo of dietary supplement to validate adherence and systemic uptake as compared to self-reported adherence and dietary records.

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

The investigators tested serum hormone levels in women assigned to omega 3 fatty acids vs. women assigned to placebo of dietary supplement to determine the effect, if any, of omega 3 fatty acids.

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

Cytokine levels in women taking oral omega 3 fatty acids were tested and compared to cytokine levels in women not taking oral omega 3 fatty acids as compared to those women who did not take omega 3 fatty acids..

Full Information

NCT ID

NCT02150525

First Posted

August 19, 2013

Last Updated

August 7, 2018

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02150525

Brief Title

Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

August 2010 (Actual)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (oral omega-3 fatty acid)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm II (placebo)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

omega-3 fatty acid

Other Intervention Name(s)

fish oil, n-3 fatty acid, O3FA, PUFAs

Intervention Description

Given PO (by mouth) daily

Intervention Type

Other

Intervention Name(s)

placebo

Other Intervention Name(s)

PLCB

Intervention Description

Given PO(by mouth)daily

Intervention Type

Behavioral

Intervention Name(s)

Questionnaire administration

Intervention Description

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).

Primary Outcome Measure Information:

Title

Description

Time Frame