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Tart Cherry + Fish Oil for Joint Pain
Phase < 1
Waitlist Available
Led By Philip Chang, DO
Research Sponsored by Philip Chang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently receiving AI therapy
Breast cancer diagnosis (Stage I-III) with any hormonal status
Must not have
Current use of anticoagulant medications (Including but not limited to Warfarin, Lovenox, Eliquis, Xarelto)
Uncontrolled diabetes mellitus as determined by treating physician (with or without the use of glucose lowering medications and/or insulin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if taking tart cherry & fish oil together can help reduce joint stiffness & other health issues in an obese breast cancer population.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Tart Cherry and Omega-3 supplements generally have fewer side effects than other medications for AIMSS such as NSAIDs or steroids. Possible mild side effects may include digestive discomfort or allergic reactions for those sensitive to cherries or fish.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on aromatase inhibitor therapy.
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I have been diagnosed with Stage I-III breast cancer.
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I have been diagnosed with AIMSS.
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My average joint pain score is 4 or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking blood thinner medications.
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My diabetes is not under control, as determined by my doctor.
Select...
I have a history of rheumatoid arthritis or other inflammatory joint diseases.
Select...
I have had a stroke or a transient ischemic attack in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The primary objective is to assess changes in joint function between groups.
Secondary study objectives
To assess changes in cognition between groups.
To assess changes in functional performance between groups.
To assess changes in nociplastic pain between groups.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tart Cherry
2023
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
The Cherry Marketing InstituteUNKNOWN
Philip ChangLead Sponsor
Philip Chang, DOPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
16 Total Patients Enrolled