Clinical trial · Interventional
Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors
A Randomized Trial to Explore the Effect of Oral Omega 3 Fatty Acids on Atrophic Vaginitis in Postmenopausal Breast Cancer Survivors
NCT02150525CI-TRIAL-00034236completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer, Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer, Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| Questionnaire administration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (oral omega-3 fatty acid)
- description
- 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.
- interventionNames
- Dietary Supplement: omega-3 fatty acid
- Behavioral: Questionnaire administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients received equivalent, matched oral placebo (seven capsules) daily for 6 months. Questionnaire administration, pills counts, and medication diaries were collected at monthly intervals.
- interventionNames
- Other: placebo
- Behavioral: Questionnaire administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.