Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
NCT ID: NCT06123286
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-09-12
2027-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1 : Wait list control
No supplement but will be offered supplements after finishing the study
No interventions assigned to this group
Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)
Tart Cherry
1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
Omega 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
Interventions
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Tart Cherry
1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
Omega 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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The Cherry Marketing Institute
UNKNOWN
Philip Chang
OTHER
Responsible Party
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Philip Chang
Sponsor-Investigator
Principal Investigators
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Philip Chang, DO
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
CS Cancer at the Hunt Cancer Center
Torrance, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT2022-08-CHANG-TaCO3AIMSS
Identifier Type: -
Identifier Source: org_study_id
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