Status:
RECRUITING
Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
Lead Sponsor:
Philip Chang
Collaborating Sponsors:
The Cherry Marketing Institute
Conditions:
Breast Cancer
Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06123286
Start Date
September 12 2025
End Date
October 1 2027
Last Update
September 19 2025
Active Locations (2)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
CS Cancer at the Hunt Cancer Center
Torrance, California, United States, 90505