Clinical trial · Interventional
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study
NCT01478477CI-TRIAL-00064287completedN/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 randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of therapy complications | Other | — | UNRESOLVED |
| Clinical assessments | Other | — | UNRESOLVED |
| Correlative/special studies | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| omega-3 fatty acid supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm I (omega-3 fatty acid supplement)
- description
- Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
- interventionNames
- Dietary Supplement: omega-3 fatty acid supplement
- Other: Clinical assessments
- Other: Assessment of therapy complications
- Procedure: Magnetic Resonance Imaging
- Procedure: Correlative/special studies
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Typical American Diet oils (TAD)
- interventionNames
- Other: Placebo
- Other: Clinical assessments
- Other: Assessment of therapy complications
- Procedure: Magnetic Resonance Imaging
- Procedure: Correlative/special studies
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 adjuvant AI therapy with any of the Food and Drug Administration- (FDA) approved AIs (anastrozole, 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 * History of osteoarthritis and/or fibromyalgia 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, with the exception of osteoarthritis and fibromyalgia * AI use \> 2 weeks prior to study enrollment * Known bleeding disorders * History of diabetes mellitus, heart disease or TIA/stroke * 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 regular or any other supplements that might interact with n-3 PUFA supplements within six months of study initiation; sporadic use of n-3 PUFA supplement may be eligible if there has been a 3-month washout period prior to randomization * Pregnant or nursing women * Known sensitivity or allergy to fish or fish oil * Concurrent use of daily full dose aspirin (≥ 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month washout period is required prior to randomization * Unable to give informed consent * In patients consenting for optional MRIs, any contraindication to MRI examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia
References
Publications (1)
- DERIVEDOrchard TS, Andridge RR, Yee LD, Lustberg MB. Diet Quality, Inflammation, and Quality of Life in Breast Cancer Survivors: A Cross-Sectional Analysis of Pilot Study Data. J Acad Nutr Diet. 2018 Apr;118(4):578-588.e1. doi: 10.1016/j.jand.2017.09.024. Epub 2017 Dec 9. PMID 29233615