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

Launched by PHILIP CHANG · Nov 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two natural supplements, Tart Cherry and Omega-3 fatty acids, on joint pain and stiffness in women with breast cancer who are experiencing muscle and joint symptoms related to their treatment. Specifically, the researchers want to see if taking these supplements together over 12 weeks can help improve joint function, pain levels, and overall quality of life compared to taking just one of the supplements alone. Previous studies in animals suggest that these two supplements might work better together than separately, although this has not yet been tested in people.

To participate in the trial, women must be at least 18 years old, diagnosed with breast cancer (Stages I-III), currently receiving hormone therapy, and experiencing moderate to severe joint pain. They should also have a body mass index (BMI) of 27 or higher and a specific level of Omega-3 in their blood. However, there are certain medical conditions and medications that could exclude someone from participating, such as allergies to cherries or fish, recent use of certain pain medications, or a history of specific joint diseases. If eligible, participants will be asked to take the supplements and attend regular check-ups to monitor their progress over the study period. This trial aims to offer a potential new approach to managing joint pain without the side effects associated with traditional medications.

Gender

FEMALE

Eligibility criteria

• 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.