RightFit
RecruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether taking tart cherry and fish oil together for 12 weeks helps joints work better than taking either supplement alone. It is for adult women with breast cancer, a BMI of 27 or higher, and muscle or joint symptoms caused by aromatase inhibitors, a type of hormone treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–III breast cancer, with any hormone status.
  • Be a woman age 18 or older.
  • Be taking an aromatase inhibitor (AI), a type of hormone treatment.
  • Have a body mass index (BMI) of 27 or higher, a measure based on height and weight.
  • Have a doctor's diagnosis of muscle or joint symptoms caused by AI treatment (AIMSS).
  • Have an Omega-3 Index below 8%, a blood measure of omega-3 fats.
  • Have an average joint pain score of at least 4 on the Brief Pain Inventory within 7 days before joining.
  • Give written consent and be able and willing to follow study rules.

Who can't join

  • Take blood thinners, such as warfarin, Lovenox, Eliquis, or Xarelto.
  • Have an allergy to cherries, fish, or fish products.
  • Have ever had rheumatoid arthritis or another disease that causes joint inflammation.
  • Have diabetes that your treating doctor says is not controlled.
  • Have ever had a stroke or a transient ischemic attack (a brief, stroke-like event).
  • Started or changed the dose of pain medicine taken by mouth or put on the skin in the past 14 days.
  • Used steroids taken by mouth or injected into a joint in the past 30 days.
  • Had a fracture or surgery in the joint with symptoms in the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CA