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NCT Number: NCT06123286

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

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.

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Key information

Conditions

Breast Cancer Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) Arthralgia Breast Diseases Breast Neoplasms Joint Diseases Joint Pain Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tart Cherry

Drug

1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks

Omega 3 FA (Fish Oil)

Drug

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

Primary outcomes

  1. The primary objective is to assess changes in joint function between groups.

    Time frame: 6 Months

    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.

Secondary outcomes

  1. To assess changes in nociplastic pain between groups.

    Time frame: 6 Months

    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.

  2. To assess changes in nociplastic pain between groups.

    Time frame: 6 Months

    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.

  3. To assess changes in functional performance between groups.

    Time frame: 6 Months

    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.

  4. To assess changes in quality of life between groups.

    Time frame: 6 Months

    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.

  5. To assess changes in cognition between groups.

    Time frame: 6 Months

    Cognition will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function 8a Short Form. The PROMIS Cognitive Function Short Form 8a score ranges from 8 to 40 with higher scores indicating better cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Philip Chang

Other

Collaborators

  • Cherry Marketing Institute

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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