Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Completed · Phase 2 · Has a placebo group

Conditions studied: Ductal Breast Carcinoma in Situ, Breast Cancer, Stage I, Breast Cancer, Stage II, Breast Cancer, Stage III

In brief

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.

Key facts

Study ID

NCT02150525

Run by

Ohio State University Comprehensive Cancer Center

People needed

52

Starts

2010-08-01

Expected to finish

2013-01-01

Last updated by the study team

2018-08-09

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

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
• 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)

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

Where it is running

• The Ohio State University Medical Center, Comprehensive Breast Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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