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 — DRUG
    1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
  • Omega 3 FA (Fish Oil) — DRUG
    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

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 control
    No 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

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
3104232133
Philip Chang, MD (PRINCIPAL_INVESTIGATOR)
Arash Asher, MD (SUB_INVESTIGATOR)
CS Cancer at the Hunt Cancer CenterTorranceCalifornia90505
Sarah Valdez
310-750-3300
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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