RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-11
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06123286

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Breast cancer diagnosis (Stage I-III) with any hormonal status.
  2. * Females aged ≥ 18 years.
  3. * Currently receiving AI therapy.
  4. * BMI ≥ 27.
  5. * Clinical diagnosis of AIMSS.
  6. * Omega-3 Index \<8%.
  7. * Average joint pain score ≥ 4 on the Brief Pain Inventory (BPI) within 7 days of enrollment.
  8. * Written informed consent obtained from subject and ability and willingness of subject to comply with the requirements of the study.
  1. * Current use of anticoagulant medications (Including but not limited to Warfarin, Lovenox, Eliquis, Xarelto).
  2. * Allergy to cherries or fish/fish products.
  3. * Lifetime history of rheumatoid arthritis and/or inflammatory joint diseases (Including but not limited to reactive arthritis, ankylosing spondylitis, and psoriatic arthritis).
  4. * Uncontrolled diabetes mellitus as determined by treating physician (with or without the use of glucose lowering medications and/or insulin).
  5. * Lifetime history of stroke or transient ischemic attacks.
  6. * 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).
  7. * Oral or intra-articular steroid use in the previous 30 days (Including but not limited to dexamethasone, prednisone, methylprednisolone, triamcinolone, hydrocortisone).
  8. * History of joint fracture or surgery of the symptomatic joint in the previous 6 months.

Contacts and Locations

Study Contact

Clinical Trial Navigator
CONTACT
3104232133
cancer.trial.info@cshs.org

Principal Investigator

Philip Chang, DO
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
CS Cancer at the Hunt Cancer Center
Torrance, California, 90505
United States

Collaborators and Investigators

Sponsor: Philip Chang

  • Philip Chang, DO, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-07-11
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-07-11
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer
  • Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
  • Joint Pain