Clinical trial NCT02150525: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 52
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

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.
timeFrame: 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.
timeFrame: From baseline to 3 and 6 months
measure: 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.
timeFrame: From baseline to 3 and 6 months
measure: Measure if effects exist from omega 3 fatty acids by using tested serum hormone levels in all participants.
timeFrame: From baseline to 3 and 6 months
measure: Determine if an effect existed in women that took omega 3 fatty acids by using tested cytokine levels in all participants.
timeFrame: From baseline to 3 and 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center, Comprehensive Breast Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joanne Lester, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References: