Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPhilip Chang
About 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 does not accept healthy volunteersQualifiers
Breast cancer diagnosis (Stage I-III) with any hormonal status.
Females aged ≥ 18 years.
Currently receiving AI therapy.
BMI ≥ 27.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Tart Cherry
Drug1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks
Omega 3 FA (Fish Oil)
Drug2 capsules of Omega 3 FA (Fish Oil) (Nordic Naturals Ultimate Omega) \[650 mg EPA and 450 mg DHA per capsule\] daily for 12 weeks
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Group 1 : Wait list controlNo intervention 0 interventions
Group B: Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The primary objective is to assess changes in joint function between groups.
Changes in joint symptoms will be assessed via the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC Pain score ranges from 0% to 100% with higher scores indicating greater difficulty with activities of daily living.
Time frame
6 MonthsSecondary outcomes
1
To assess changes in nociplastic pain between groups.
Changes in nociplastic pain will be measured by composite score on Symptom Severity Scale. The Symptom Severity Scale ranges from 0-12 with higher scores equating to increased nociplastic pain.
Time frame
6 Months2
To assess changes in nociplastic pain between groups.
Changes in nociplastic pain will be measured by composite score on Widespread Pain Index. The Widespread Pain Index score ranges from 0-19 with higher scores equating to increased nociplastic pain.
Time frame
6 Months3
To assess changes in functional performance between groups.
Functional Performance will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer 3D Function Profile. The PROMIS Cancer 3D Function Profile has 3 subgroups including Physical Function, Fatigue and Social Participation. The Physical Function score ranges from 5-30 with higher scores equating to better function. The Fatigue score ranges from 3-15 with higher scores equating to less fatigue. The Social Participation score ranges from 3-15 with higher scores equating to worse social participation.
Time frame
6 Months4
To assess changes in quality of life between groups.
Quality of Life will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) PROMIS-29+2. The PROMIS-29+2 has 8 subgroups including physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, pain interference and cognitive function. All subgroups are scored from 4-20 except for cognitive function which is scored from 2-10.
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Philip Chang
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Cherry Marketing Institute
Collaborator
Source ClinicalTrials.gov