Clinical trial NCT06123286: Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
Official title: An Open Label, Randomized, Waitlist Controlled Trial of Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Joint Pain
Keywords: Aromatase Inhibitor Therapy
AIMSS
Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Tart Cherry
Omega 3 Fatty Acids Fish Oil
Female Breast Cancer
Aromatase Inhibitor Arthralgia
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: The Cherry Marketing Institute
First posted: 2023-11-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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 \&lt;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.

Primary outcomes:
measure: The primary objective is to assess changes in joint function between groups.
timeFrame: 6 Months
Secondary outcomes:
measure: To assess changes in nociplastic pain between groups.
timeFrame: 6 Months
measure: To assess changes in nociplastic pain between groups.
timeFrame: 6 Months
measure: To assess changes in functional performance between groups.
timeFrame: 6 Months
measure: To assess changes in quality of life between groups.
timeFrame: 6 Months
measure: To assess changes in cognition between groups.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Torrance
country: United States
facility: CS Cancer at the Hunt Cancer Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Philip Chang, DO
role: PRINCIPAL_INVESTIGATOR
References: