Trial Summary
What is the purpose of this trial?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 Criteria
This trial is for women over 18 with breast cancer stages I-III, currently on AI therapy, BMI ≥ 27, and experiencing joint pain from the treatment. They must have an Omega-3 Index <8%, a clinical diagnosis of AIMSS, and a certain level of joint pain. Excluded are those with stroke history, anticoagulant use, cherry or fish allergies, inflammatory joint diseases, recent changes in pain medication use or steroid use.Inclusion Criteria
I am currently on aromatase inhibitor therapy.
You are considered overweight based on your height and weight.
I have been diagnosed with Stage I-III breast cancer.
+5 more
Exclusion Criteria
You are allergic to cherries or fish/fish products.
I am currently taking blood thinner medications.
My diabetes is not under control, as determined by my doctor.
+5 more
Participant Groups
The study tests if Tart Cherry concentrate combined with fish oil can reduce arthritis symptoms in obese breast cancer patients suffering from AIMSS during a 12-week period compared to a control group. It also looks at secondary outcomes like pain relief and quality of life improvements.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)Experimental Treatment2 Interventions
Group II: Group 1 : Wait list controlActive Control1 Intervention
No supplement but will be offered supplements after finishing the study
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
CS Cancer at the Hunt Cancer CenterTorrance, CA
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Who Is Running the Clinical Trial?
Philip ChangLead Sponsor
The Cherry Marketing InstituteCollaborator