Breast CancerEarly Phase 1NCT06123286
Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
A Early Phase 1 study testing Tart Cherry and Omega 3 FA (Fish Oil) in people with Breast Cancer and Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), run by Philip Chang at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Joint Pain
- What is being tested?
- Tart Cherry and Omega 3 FA (Fish Oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2025to Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Philip Chang, MD
- Not yet recruiting
CS Cancer at the Hunt Cancer Center
Torrance, California, 90505
Sarah Valdez, 310-750-3300 ext. 73422, Sarah.Valdez@tmphysicians.com
David Chan, MD
About this study
Official title: An Open Label, Randomized, Waitlist Controlled Trial of 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.
- Conditions
- Breast Cancer, Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Joint Pain
- Being tested
- Tart Cherry, Omega 3 FA (Fish Oil)
- 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
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart CherryDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Wait list control | No intervention | No supplement but will be offered supplements after finishing the study |
| Group 2 : Tart Cherry and Omega 3 FA (Fish Oil) | Experimental | Not described Receives: Drug: Tart Cherry; Drug: Omega 3 FA (Fish Oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (5)
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.
Measured: 6 Months
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.
Measured: 6 Months
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.
Measured: 6 Months
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.
Measured: 6 Months
To assess changes in cognition between groups.
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start12 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philip Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Marketing Institute
- Responsible party
- Sponsor-investigator, Philip Chang, Cedars-Sinai Medical Center
- Investigators
- Philip Chang, DO, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123286
- Sponsor's protocol ID
- IIT2022-08-CHANG-TaCO3AIMSS
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Waitlist Controlled Trial of Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
- ClinicalTrials.gov ID
- NCT06123286
- Acronym / sponsor ID
- IIT2022-08-CHANG-TaCO3AIMSS
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Philip ChangUniversity, hospital or other
- Collaborators
- Cherry Marketing Institute
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Wait list control | No intervention | –No supplement but will be offered supplements after finishing the study |
| Group 2 : Tart Cherry and Omega 3 FA (Fish Oil) | Experimental | Drug: Tart Cherry, Drug: Omega 3 FA (Fish Oil) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Breast cancer diagnosis (Stage I-III) with any hormonal status.
- Females aged ≥ 18 years.
- Currently receiving AI therapy.
- BMI ≥ 27.
- Clinical diagnosis of AIMSS.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tart Cherry1 ounce of Tart Cherry Concentrate (King Orchard) mixed with 8 ounces of water daily for 12 weeks | Drug | Group 2 : Tart Cherry and Omega 3 FA (Fish Oil) |
| Omega 3 FA (Fish Oil)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 | Drug | Group 2 : Tart Cherry and Omega 3 FA (Fish Oil) |
Primary outcome
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.
5 secondary outcomes
To assess changes in nociplastic pain between groups.
Time frame: 6 Months
To assess changes in nociplastic pain between groups.
Time frame: 6 Months
To assess changes in functional performance between groups.
Time frame: 6 Months
To assess changes in quality of life between groups.
Time frame: 6 Months
To assess changes in cognition between groups.
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Chang, DO principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tart Cherry and Omega 3 FA (Fish Oil) in people with Breast Cancer and Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), run by Philip Chang at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to assess changes in joint function between groups. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.