Tart cherry and fish oil for aromatase inhibitor–related joint pain
An Open Label, Randomized, Waitlist Controlled Trial of Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
This project will test whether taking tart cherry concentrate plus fish oil for 12 weeks reduces joint pain and stiffness in women with breast cancer who are taking aromatase inhibitors.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06123286 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional project gives participants tart cherry concentrate, fish oil, or a combination over a 12-week period to measure changes in joint function and pain. Enrollment targets women with stage I–III breast cancer who are actively receiving aromatase inhibitor therapy and meet specified criteria (including BMI ≥27, Omega-3 index <8%, and average joint pain ≥4). Outcomes will focus on patient-reported joint pain and stiffness, with biochemical and functional measures used as secondary endpoints. The work is conducted at Cedars-Sinai sites in Los Angeles and Torrance, California.
Who should consider this trial
Good fit: Ideal candidates are adult women with stage I–III breast cancer on aromatase inhibitors who have BMI ≥27, an Omega-3 index below 8%, and moderate-to-severe joint pain (average BPI ≥4).
Not a fit: People taking anticoagulant medications, with allergies to cherries or fish, with inflammatory arthritides, uncontrolled diabetes, or a history of stroke/TIA are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could offer a lower-risk, supplement-based option to help reduce AIMSS-related pain and stiffness.
How similar studies have performed: Preclinical mouse studies suggest the two supplements may have additive anti-inflammatory effects, but to our knowledge no prior human trials have tested this specific combination for AIMSS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast cancer diagnosis (Stage I-III) with any hormonal status. * Females aged ≥ 18 years. * Currently receiving AI therapy. * BMI ≥ 27. * Clinical diagnosis of AIMSS. * Omega-3 Index \<8%. * Average joint pain score ≥ 4 on the Brief Pain Inventory (BPI) within 7 days of enrollment. * Written informed consent obtained from subject and ability and willingness of subject to comply with the requirements of the study. Exclusion Criteria: * Current use of anticoagulant medications (Including but not limited to Warfarin, Lovenox, Eliquis, Xarelto). * Allergy to cherries or fish/fish products. * Lifetime history of rheumatoid arthritis and/or inflammatory joint diseases (Including but not limited to reactive arthritis, ankylosing spondylitis, and psoriatic arthritis). * Uncontrolled diabetes mellitus as determined by treating physician (with or without the use of glucose lowering medications and/or insulin). * Lifetime history of stroke or transient ischemic attacks. * New use or dose change of oral or topical analgesics in the previous 14 days. (Including but not limited to opioids, non-steroidal anti-inflammatories, acetaminophen, SNRI's, SSRI's, gabapentinoids, tricyclic antidepressants, and muscle relaxants). * Oral or intra-articular steroid use in the previous 30 days (Including but not limited to dexamethasone, prednisone, methylprednisolone, triamcinolone, hydrocortisone). * History of joint fracture or surgery of the symptomatic joint in the previous 6 months.
Where this trial is running
Los Angeles, California and 1 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- CS Cancer at the Hunt Cancer Center — Torrance, California, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Philip Chang, DO — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.