Breast CancerPhase 2NCT06268665
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
A Phase 2 study testing Tart Cherry Juice in people with Breast Cancer and Breast Cancer Stage I, run by University of California, Davis at 1 site in United States.
Trial summary
This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- Tart Cherry Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to Dec 2027
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.
- Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.
- Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.
- Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.
- Concurrent use of immune checkpoint inhibitor therapy is allowed.
- (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.
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- Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.
- May participate concurrently in other cancer trials.
- Must be able to complete questionnaires in English or Spanish.
- Age ≥ 18 years old at the time of consent.
- ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:
- A stable regimen of highly active anti-retroviral therapy (HAART)
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
- A CD4 count above 250 cells/µL and an undetectable HIV viral load on standard PCR-based tests within the last year.
- Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.
- Ability and willingness to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).
- Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.
- Currently taking anticoagulant medication.
- Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements/medications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E > 1,000 international units (IU) must be discontinued at the time of registration.
- Patients may not use cold therapy gloves for chemotherapy induced neuropathy.
- Known allergy to cherries.
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- Inability to swallow liquid.
- Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).
- Any condition that would prohibit the understanding or rendering of informed consent.
- Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95827
Eve Rodler, MD, 916-734-5409, erodler@ucdavis.edu
Eve Rodler, MD
About this study
Official title: A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.
Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).
Read the detailed description
PRIMARY OBJECTIVE: I. Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
SECONDARY OBJECTIVE:
- Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
II. Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
III. Ascertain the tolerability and side effects of intake of high-dose and low-dose tart cherry juice OUTLINE: Tart cherry juice in both arms must begin ≤ 7 days from start of taxane therapy. During treatment, each participant in the high-dose group will consume 1 oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 196 oz). Each participant in the low-dose group will consume ¼ oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 49 oz). Participants will have follow-up visits at the conclusion of chemotherapy and at 12 months.
- Conditions
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage IV, Invasive Breast Cancer
- Being tested
- Tart Cherry Juice
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart Cherry JuiceDrug
Also called Juice extracted from Montmorency cherries, Juice from Prunus cerasus
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: High-Dose Tart Cherry Juice Supplement | Experimental | 1 oz tart cherry juice concentrate diluted in water up to 8oz. Receives: Drug: Tart Cherry Juice |
| Arm 2: Low-Dose Tart Cherry Juice Supplement | Experimental | ¼ oz tart cherry juice concentrate diluted in water up to 8oz. Receives: Drug: Tart Cherry Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
Number of participants between study arms experiencing PIPN using the 11-item peripheral neuropathy component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) survey.
Measured: Up to 1 year.
Secondary outcomes (4)
Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
Assessment of the severity of PIPN using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) neuropathy subscale survey and National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v.5) physician assessment.
Measured: Up to 1 year.
Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
Number of participants between arms experiencing dose reductions, delays, or discontinuations.
Measured: Up to 1 year.
Tolerability of daily intake of high-dose and low-dose tart cherry juice.
Number of participants between study arms ≥90% compliant with daily consumption of tart cherry juice.
Measured: Up to 1 year.
Safety profile of daily intake of high-dose and low-dose tart cherry juice.
Number of participants between study arms with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5).
Measured: Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Aug 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Rodler, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268665
- Sponsor's protocol ID
- UCDCC307
- Other IDs
- NCI-2024-02360, UCDCC307
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
- ClinicalTrials.gov ID
- NCT06268665
- Acronym / sponsor ID
- UCDCC307
- Conditions
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage IV, Invasive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Feb 2024 (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.
This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.
Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).
Detailed description
PRIMARY OBJECTIVE: I. Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
SECONDARY OBJECTIVE:
- Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
II. Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
III. Ascertain the tolerability and side effects of intake of high-dose and low-dose tart cherry juice OUTLINE: Tart cherry juice in both arms must begin ≤ 7 days from start of taxane therapy. During treatment, each participant in the high-dose group will consume 1 oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 196 oz). Each participant in the low-dose group will consume ¼ oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 49 oz). Participants will have follow-up visits at the conclusion of chemotherapy and at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: High-Dose Tart Cherry Juice Supplement | Experimental | Drug: Tart Cherry Juice1 oz tart cherry juice concentrate diluted in water up to 8oz. |
| Arm 2: Low-Dose Tart Cherry Juice Supplement | Experimental | Drug: Tart Cherry Juice¼ oz tart cherry juice concentrate diluted in water up to 8oz. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.
- Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.
- May participate concurrently in other cancer trials.
- Must be able to complete questionnaires in English or Spanish.
- Age ≥ 18 years old at the time of consent.
Key exclusion criteria (10 listed)
- Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).
- Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.
- Currently taking anticoagulant medication.
- Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements/medications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E > 1,000 international units (IU) must be discontinued at the time of registration.
- Patients may not use cold therapy gloves for chemotherapy induced neuropathy.
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 Cherry JuiceAlso: Juice extracted from Montmorency cherries, Juice from Prunus cerasusGiven PO | Drug | Arm 1: High-Dose Tart Cherry Juice Supplement, Arm 2: Low-Dose Tart Cherry Juice Supplement |
Primary outcome
Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
Time frame: Up to 1 year.
Number of participants between study arms experiencing PIPN using the 11-item peripheral neuropathy component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) survey.
4 secondary outcomes
Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
Time frame: Up to 1 year.
Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
Time frame: Up to 1 year.
Tolerability of daily intake of high-dose and low-dose tart cherry juice.
Time frame: Up to 1 year.
Safety profile of daily intake of high-dose and low-dose tart cherry juice.
Time frame: Up to 1 year.
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 Mar 2026.
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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.
Eve Rodler, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tart Cherry Juice in people with Breast Cancer and Breast Cancer Stage I, run by University of California, Davis at 1 site 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 19 inclusion and 10 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Eve Rodler, MD (916-734-5959, erodler@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. (time frame: Up to 1 year.). 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 Mar 2026.