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
1 other identifier
interventional
30
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 breast-cancer
Started Sep 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
September 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
May 5, 2026
May 1, 2026
2.1 years
October 16, 2023
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to assess changes in joint function between groups.
Changes in joint symptoms will be assessed via the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC Pain score ranges from 0% to 100% with higher scores indicating greater difficulty with activities of daily living.
6 Months
Secondary Outcomes (5)
To assess changes in nociplastic pain between groups.
6 Months
To assess changes in nociplastic pain between groups.
6 Months
To assess changes in functional performance between groups.
6 Months
To assess changes in quality of life between groups.
6 Months
To assess changes in cognition between groups.
6 Months
Study Arms (2)
Group 1 : Wait list control
NO INTERVENTIONNo supplement but will be offered supplements after finishing the study
Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)
EXPERIMENTALInterventions
1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cherry Marketing Institutecollaborator
- Philip Changlead
Study Sites (2)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
CS Cancer at the Hunt Cancer Center
Torrance, California, 90505, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Chang, DO
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
October 16, 2023
First Posted
November 8, 2023
Study Start
September 12, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share