A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: omega-3 fatty acid (Dietary Supplement)
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.
干预措施: Questionnaire administration (Behavioral)
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.
干预措施: placebo (Other)
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.
干预措施: Questionnaire administration (Behavioral)
结局指标
主要结局
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.
时间窗: From baseline to 3 and 6 months
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.
次要结局
- 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.(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.(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.(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.(From baseline to 3 and 6 months)