Clinical trial · Interventional
Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
NCT02831582CI-TRIAL-00064277completedN/AClinicalTrials.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 clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega-3 Fatty Acid | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (omega-3 fatty acid)
- description
- Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
- interventionNames
- Dietary Supplement: Omega-3 Fatty Acid
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO QD for 6 months.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change in pain score based on the Brief Pain Inventory (BPI)
- timeFrame
- Baseline to up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole) * Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed. * Prior tamoxifen use is allowed * Prior chemotherapy is allowed * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Metastatic malignancy of any kind * Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease * AI use \> 21 days prior to study enrollment * Known bleeding disorders * Current use of warfarin or other anticoagulants * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements * Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if \> 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation * Pregnant or nursing women * Known sensitivity or allergy to fish or fish oil * Unable to give informed consent
References
Publications (1)
- DERIVEDRoberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2. PMID 35005781