Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Breast Neoplasms

Pain

Arthralgia

Joint Diseases

Neurologic Manifestations

All Drugs and Chemicals

Other Dietary Supplements

Aromatase Inhibitors

Omega 3 Fatty Acid

No supplement but will be offered supplements after finishing the study

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

Tart Cherry

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

Omega 3 FA (Fish Oil)

Clinical Trial Navigator

Clinical Trial Recruitment Navigator

Philip Chang, MD

Arash Asher, MD

Sarah Valdez

David Chan, MD

Vanessa Dickey, MD

Hugo Hool, MD

Syed Jilani, MD

Thomas Lowe, MD

Swati Sikaria, MD

Philip Chang, DO

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 the investigators 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 some evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately. 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 arthritis symptoms when compared to a control group in an obese breast cancer population experience AIMSS and on an AI. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.

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

Changes in arthritis 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.

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.

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.

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.

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.

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.

The Cherry Marketing Institute

Philip Chang

Sponsor-Investigator

Syndrome

Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.

At baseline, patients will undergo a blood draw.

Initial blood draw

At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Initial SWE ultrasound

Blood drawn at three months to evaluate oxylipins.

Blood draw at three months

Blood drawn at six months to evaluate oxylipins.

Blood draw at six months

SWE ultrasound at six months to evaluate tendon stiffness.

SWE ultrasound at six months

Pavani Chalasani

This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers

Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome

Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome

Change Oxylipin levels at Baseline, Three and Six Months

Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20.

University of Arizona

This is a pilot trial to evaluate oxylipins as blood biomarkers of aromatase inhibitor induced musculoskeletal syndrome. Adverse events were monitored for blood draws and analysis of oxylipins only. Anastrozole treatment was done as standard of care, and thus, side effects from anastrozole were managed per patients' standard of care and were not recorded for the purposes of this study.

Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.

Initial blood draw: At baseline, patients will undergo a blood draw.

Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Blood draw at three months: Blood drawn at three months to evaluate oxylipins.

Blood draw at six months: Blood drawn at six months to evaluate oxylipins.

SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.

Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Staging is based on the patients' surgical pathology report. American Joint Committee on Cancer (AJCC) 7th staging criteria for breast cancer was used for this study. Overall 7th Edition AJCC stage (IIV) is based on the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms	NCT06123286	Breast Cancer Aromatase Inhib... Joint Pain	Tart Cherry Omega 3 FA (Fis...	18 Years -	Cedars-Sinai Medical Center
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome	NCT03665077	Aromatase Inhib... Breast Cancer	Initial blood d... Initial SWE ult... Blood draw at t... Blood draw at s... SWE ultrasound ...	21 Years -	University of Arizona

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Spots Global Cancer Trial Database for aimss

Every month we try and update this database with for aimss cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aimss cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.