Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: omega-3 fatty acid
* Other: placebo
* Behavioral: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (oral omega-3 fatty acid)<br>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. | Dietary Supplement: omega-3 fatty acid<br>* Given PO (by mouth) daily<br>* Other names: PUFAs;Behavioral: Questionnaire administration<br>* 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).<br>|
| Placebo Comparator: Arm II (placebo)<br>Patients received equivalent, matched oral placebo (seven capsules) daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals. | Other: placebo<br>* Given PO(by mouth)daily<br>* Other names: PLCB;Behavioral: Questionnaire administration<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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.. | From baseline to 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, vaginal dryness, dyspareunia, genital irritation