Trial Title:
Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
NCT ID:
NCT06123286
Condition:
Breast Cancer
Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Joint Pain
Conditions: Official terms:
Arthralgia
Conditions: 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
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tart Cherry
Description:
1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for
12 weeks
Arm group label:
Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)
Intervention type:
Drug
Intervention name:
Omega 3 FA (Fish Oil)
Description:
2 capsules of Omega 3 FA (Fish Oil) (Nordic Naturals Ultimate Omega) [650 mg EPA and 450
mg DHA per capsule] daily for 12 weeks
Arm group label:
Group 2 : Tart Cherry and Omega 3 FA (Fish Oil)
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Contact:
Last name:
Clinical Trial Recruitment Navigator
Phone:
310-423-2133
Email:
cancer.trial.info@cshs.org
Investigator:
Last name:
Philip Chang, MD
Email:
Principal Investigator
Investigator:
Last name:
Arash Asher, MD
Email:
Sub-Investigator
Facility:
Name:
CS Cancer at the Hunt Cancer Center
Address:
City:
Torrance
Zip:
90505
Country:
United States
Contact:
Last name:
Sarah Valdez
Phone:
310-750-3300
Phone ext:
73422
Email:
Sarah.Valdez@tmphysicians.com
Investigator:
Last name:
David Chan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Vanessa Dickey, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hugo Hool, MD
Email:
Sub-Investigator
Investigator:
Last name:
Syed Jilani, MD
Email:
Sub-Investigator
Investigator:
Last name:
Thomas Lowe, MD
Email:
Sub-Investigator
Investigator:
Last name:
Swati Sikaria, MD
Email:
Sub-Investigator
Start date:
November 2024
Completion date:
November 2026
Lead sponsor:
Agency:
Philip Chang
Agency class:
Other
Collaborator:
Agency:
The Cherry Marketing Institute
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123286
