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

May 1, 2026 updated by: Philip Chang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Sub-Investigator:
          • Arash Asher, MD
        • Principal Investigator:
          • Philip Chang, MD
        • Contact:
      • Torrance, California, United States, 90505
        • Not yet recruiting
        • CS Cancer at the Hunt Cancer Center
        • Sub-Investigator:
          • Syed Jilani, MD
        • Sub-Investigator:
          • David Chan, MD
        • Sub-Investigator:
          • Vanessa Dickey, MD
        • Sub-Investigator:
          • Hugo Hool, MD
        • Sub-Investigator:
          • Thomas Lowe, MD
        • Sub-Investigator:
          • Swati Sikaria, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Tart Cherry
1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective is to assess changes in joint function between groups.
Time Frame: 6 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess changes in nociplastic pain between groups.
Time Frame: 6 Months
Changes in nociplastic pain will be measured by composite score on Symptom Severity Scale. The Symptom Severity Scale ranges from 0-12 with higher scores equating to increased nociplastic pain.
6 Months
To assess changes in nociplastic pain between groups.
Time Frame: 6 Months
Changes in nociplastic pain will be measured by composite score on Widespread Pain Index. The Widespread Pain Index score ranges from 0-19 with higher scores equating to increased nociplastic pain.
6 Months
To assess changes in functional performance between groups.
Time Frame: 6 Months
Functional Performance will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer 3D Function Profile. The PROMIS Cancer 3D Function Profile has 3 subgroups including Physical Function, Fatigue and Social Participation. The Physical Function score ranges from 5-30 with higher scores equating to better function. The Fatigue score ranges from 3-15 with higher scores equating to less fatigue. The Social Participation score ranges from 3-15 with higher scores equating to worse social participation.
6 Months
To assess changes in quality of life between groups.
Time Frame: 6 Months
Quality of Life will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) PROMIS-29+2. The PROMIS-29+2 has 8 subgroups including physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, pain interference and cognitive function. All subgroups are scored from 4-20 except for cognitive function which is scored from 2-10.
6 Months
To assess changes in cognition between groups.
Time Frame: 6 Months
Cognition will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function 8a Short Form. The PROMIS Cognitive Function Short Form 8a score ranges from 8 to 40 with higher scores indicating better cognitive function.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philip Chang

Collaborators

Cherry Marketing Institute

Investigators

  • Principal Investigator: Philip Chang, DO, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2022-08-CHANG-TaCO3AIMSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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