Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Philip Chang
- Study ID
- NCT06123286
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
- Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
- Breast Cancer
- Joint Pain
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tart Cherry — DRUG1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
- Omega 3 FA (Fish Oil) — DRUG2 capsules of Omega 3 FA (Fish Oil) (Nordic Naturals Ultimate Omega) \[650 mg EPA and 450 mg DHA per capsule\] daily for 12 weeks
Study Details
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 norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia. There is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.
Key Dates
- Start date
- Sep 12, 2025
- Status verified
- May 2026
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: Group 1 : Wait list controlNo supplement but will be offered supplements after finishing the study
- Experimental: Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)
Primary Outcome Measure
The primary objective is to assess changes in joint function between groups. [ Time Frame: 6 Months ]
Central Contacts
- Clinical Trial Navigator3104232133
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Philip Chang, MD (PRINCIPAL_INVESTIGATOR) Arash Asher, MD (SUB_INVESTIGATOR) |
| CS Cancer at the Hunt Cancer Center | Torrance | California | 90505 | David Chan, MD (SUB_INVESTIGATOR) Vanessa Dickey, MD (SUB_INVESTIGATOR) Hugo Hool, MD (SUB_INVESTIGATOR) Syed Jilani, MD (SUB_INVESTIGATOR) Thomas Lowe, MD (SUB_INVESTIGATOR) Swati Sikaria, MD (SUB_INVESTIGATOR) |
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