Overview

This trial is active, not recruiting.

Conditions ductal breast carcinoma in situ, breast cancer, stage i, breast cancer, stage ii, breast cancer, stage iii
Treatments omega-3 fatty acid, placebo, questionnaire administration
Phase phase 2
Sponsor Ohio State University Comprehensive Cancer Center
Start date August 2010
End date January 2013
Trial size 52 participants
Trial identifier NCT02150525, NCI-2013-00068, OSU-09145

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(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.
omega-3 fatty acid fish oil
Given PO (by mouth) daily
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).
(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.
placebo PLCB
Given PO(by mouth)daily
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).

Primary Outcomes

Measure
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.
time frame: From baseline to 3 and 6 months

Secondary Outcomes

Measure
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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: From baseline to 3 and 6 months

Eligibility Criteria

Female participants from 45 years up to 65 years old.

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

Additional Information

Official title A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors
Principal investigator Joanne Lester, PhD, CRNP
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.