RecruitingEarly Phase 1NCT06123286

Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms

An Open Label, Randomized, Waitlist Controlled Trial of Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms


Sponsor

Philip Chang

Enrollment

30 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tart cherry and omega-3 fish oil supplements can reduce joint pain in women with breast cancer who are taking aromatase inhibitors — a type of hormone-blocking drug that commonly causes joint and muscle aches as a side effect. **You may be eligible if...** - You are a woman aged 18 or older with stage I–III breast cancer - You are currently taking an aromatase inhibitor (such as anastrozole, letrozole, or exemestane) - You have joint pain related to the aromatase inhibitor (average pain score of 4 or higher on a scale of 0–10) - Your BMI is 27 or higher - Your omega-3 blood level is below 8% **You may NOT be eligible if...** - You are taking blood thinners (such as warfarin, Eliquis, or Xarelto) - You are allergic to cherries or fish products - You have rheumatoid arthritis or other inflammatory joint diseases - You have uncontrolled diabetes - You have had a stroke or mini-stroke (TIA) - You have recently started or changed pain medications (within the past 14 days) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTart Cherry

1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks

DRUGOmega 3 FA (Fish Oil)

2 capsules of Omega 3 FA (Fish Oil) (Nordic Naturals Ultimate Omega) \[650 mg EPA and 450 mg DHA per capsule\] daily for 12 weeks


Locations(2)

Cedars-Sinai Medical Center

Los Angeles, California, United States

CS Cancer at the Hunt Cancer Center

Torrance, California, United States

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NCT06123286


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