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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
CS Cancer at the Hunt Cancer Center
NOT_YET_RECRUITING
Torrance
Contact Information
Primary
Clinical Trial Navigator
cancer.trial.info@cshs.org
3104232133
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2027-10
Participants
Target number of participants: 30
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Philip Chang
Collaborators: The Cherry Marketing Institute

This content was sourced from clinicaltrials.gov