Recruiting
Early Phase 1

Tart Cherry & Omega 3

Sponsor:

Philip Chang

Code:

NCT06123286

Conditions

Breast Cancer

Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Joint Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tart Cherry

Omega 3 FA (Fish Oil)

Study Details

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.

Conditions

Breast Cancer

Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Joint Pain

Study ID

NCT06123286

Start date

Sep 12, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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)

Interventions

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

Primary outcome measure

  • The primary objective is to assess changes in joint function between groups. [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Clinical Trial Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Principal Investigator:

Philip Chang, MD

More Information

Sponsor

Philip Chang

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • Aromatase Inhibitor Therapy
  • AIMSS
  • Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
  • Tart Cherry
  • Omega 3 Fatty Acids Fish Oil
  • Female Breast Cancer
  • Aromatase Inhibitor Arthralgia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philip Chang on 2026-08-04.