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Breast CarcinomaPhase 2NCT06731894

Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

A Phase 2 study testing Biospecimen Collection, Cannabidiol and Dronabinol in people with Breast Carcinoma and Chemotherapy-Induced Peripheral Neuropathy, run by City of Hope Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trials evaluates how well different types of phytocannabinoids (cannabidiol [CBD] versus tetrahydrocannabinol [THC] and CBD formulation [THC:CBD]) work to reduce chronic chemotherapy-induced peripheral neuropathy among breast and colon cancer survivors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cannabidiol and Dronabinol
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesUnited States
Study dates
3 Oct 2025to 7 Jan 2028
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

  • Documented informed consent of the participant and/or legally authorized representative.
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Willingness to comply with all study interventions including the use of medical cannabis and follow-up assessments
  • Age: ≥ 18 years
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  • Eastern Cooperative Oncology Group Performance Status Scale (ECOG) score ≤ 2
  • Ability to read and understand English for questionnaires
  • Patients must have either neuropathy ≥ 1 according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 scale or a neuropathy score of > 3 on a 0-10 scale plus a FACT/GOG-Ntx score of > 10
  • The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team
  • Total bilirubin ≤ 1.5 X upper limits of normal (ULN) (unless has Gilbert's disease) (To be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Aspartate aminotransferase (AST) ≤ 3 x ULN (To be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Alanine aminotransferase (ALT) ≤ 3 x ULN (To be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (To be performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy.
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Current active treatment with chemotherapy, radiation or surgery in the past 3 months or planned treatment during this study protocol period. Note: Hormonal therapy is allowed
  • Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy within the past 6 months
  • Concurrent use of other alternative medicines such as medical cannabis, herbal agents and high dose vitamins and minerals
  • Liver cirrhosis Child-Pugh B or C
  • Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
  • History of diabetic neuropathy, neuropathy related to HIV, or other medical causes of chronic neuropathy in the baseline assessment including past medical history, any history of diabetes, alcoholism, and vitamin B deficiency
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  • Previous medical cannabis use for any indication within 30 days of enrollment
  • Planned or actual changes in type of medications that could affect symptoms related to CIPN. New medications for the treatment of CIPN are not allowed during the study.
  • Subjects need to be on stable doses of CIPN medications for 4 weeks
  • Strong inhibitors or inducers of CYP3A4
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  • Clinically significant uncontrolled illness
  • Diagnosis of Gilbert's disease
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
  • Patients who have an allergy or an aversion to strawberry or strawberry flavoring

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

  • City of Hope Medical Center

    Duarte, California, 91010

    Richard T. Lee, 949-671-4091, richlee@coh.org

    Richard Lee

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Richard Lee, 949-671-4091, richlee@coh.org

    Richard Lee

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

This phase II trials evaluates how well different types of phytocannabinoids (cannabidiol [CBD] versus tetrahydrocannabinol [THC] and CBD formulation [THC:CBD]) work to reduce chronic chemotherapy-induced peripheral neuropathy among breast and colon cancer survivors. Chemotherapy induced peripheral neuropathy is a set of symptoms that includes pain, tingling, numbness and motor weakness caused by certain types of chemotherapy treatment. Phytocannabinoids are compounds made by the cannabis plant, such as THC and CBD, that have been found to be an effective treatment for chronic pain. Phytocannabinoids may be effective in reducing chronic chemotherapy-induced peripheral neuropathy symptoms in patients treated for breast or colon cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Assess the ability of CBD and THC:CBD to reduce chronic chemotherapy-induced peripheral neuropathy (CIPN) symptoms as compared to placebo using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) among breast and colon cancer survivors.

SECONDARY OBJECTIVES:

  1. Evaluate the impact of CBD and THC:CBD as compared to placebo on quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) among breast and colon cancer survivors with chronic CIPN.

II. Document the utilization of neuropathic and pain medications by cancer patients with chronic CIPN during treatment with CBD and THC:CBD as compared to placebo.

III. Describe the side effects of CBD and THC:CBD treatment.

EXPLORATORY OBJECTIVES:

  1. Assess neurological symptoms and function with the Neuropathy Pain Scale (NPS), Total Neuropathy Score - Clinically Based (TNSc), Quantitative Sensory Testing (QST), Grooved Pegboard Test (GPT), Timed Up and Go (TUG) Test, and Unipedal Stance Balance Test (USBT) among patients with chronic CIPN treated with CBD and THC:CBD as compared to placebo.

II. Evaluate for predictors of response to CBD and THC:CBD for chronic CIPN.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive CBD orally (PO) once daily (QD) on days 1-3 of cycle 1, twice daily (BID) on days 4-6 of cycle 1, and three times daily (TID) on days 7-28 of cycle 1. Patients receive CBD PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.

ARM II: Patients receive THC:CBD PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive THC:CBD PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.

ARM III: Patients receive placebo PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive placebo PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.

After completion of study treatment, patients are followed up at 28 days.

Being tested
Biospecimen Collection, Cannabidiol, Dronabinol, Placebo Administration, Survey Administration
Medical subject headings
Breast Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo urine sample collection

  • CannabidiolDrug

    Also called CBD, CBD Oil, Epidiolex, GWP42003-P

    Given PO

  • DronabinolDrug

    Also called (-)-.DELTA.9-Tetrahydrocannabinol, Abbott 40566, Delta(9)-Tetrahydrocannibinol, Delta-9-Tetrahydrocannabinol

    Given PO

  • Placebo AdministrationDrug

    Given PO

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06731894
Study groupRoleWhat they receive
Arm I (CBD)ExperimentalPatients receive CBD PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive CBD PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.
Receives: Procedure: Biospecimen Collection; Drug: Cannabidiol; Other: Survey Administration
Arm II (THC:CBD)ExperimentalPatients receive THC:CBD PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive THC:CBD PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.
Receives: Procedure: Biospecimen Collection; Drug: Cannabidiol; Drug: Dronabinol; Drug: Placebo Administration; Other: Survey Administration
Arm III (placebo)Placebo comparatorPatients receive placebo PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive placebo PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.
Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjectively experienced symptoms of peripheral neuropathy

    Assessed via Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Subscale (FACT/GOG-Ntx). Will compare difference scores from the FACT/GOG-Ntx between all these groups using analysis of variance. A paired t-test will be utilized to compare scores between baseline and 8 and 12 weeks of treatment for each group separately.

    Measured: Up to 28 days after last dose of therapy

Secondary outcomes (4)

  1. Health-related quality of life

    Assessed via Functional Assessment of Cancer Therapy-General. A paired T-test will be utilized to compare scores between baseline and 8 weeks of treatment. For comparisons between groups at four specific assessment points (baseline, week 4, week 8, and week 12), a repeated measures analysis of variance analysis will be performed.

    Measured: Up to 28 days after last dose of therapy

  2. Neuropathic medication utilization

    Neuropathic medication utilization data will initially be analyzed as a dichotomous variable (yes/no) for each medication. Comparisons between the baseline and after-treatment medication status will be analyzed using McNemar's test. Including all the time points in the analysis of any single medication will use Cochran's Q test.

    Measured: Up to 28 days after last dose of therapy

  3. Pain medication utilization

    Pain medication utilization data will initially be analyzed as a dichotomous variable (yes/no) for each medication. Comparisons between the baseline and after-treatment medication status will be analyzed using McNemar's test. Including all the time points in the analysis of any single medication will use Cochran's Q test.

    Measured: Up to 28 days after last dose of therapy

  4. Incidence of adverse events

    All adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0. The severe adverse events (SAE) (grade ≥ 3) will be tabulated per treatment arm and the difference of SAE will be compared among groups using chi-square test.

    Measured: Up to 28 days after last dose of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start3 Oct 2025
  3. Primary completion7 Jan 2028 (estimated)
  4. Study completion7 Jan 2028 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731894
Sponsor's protocol ID
24435
Other IDs
NCI-2024-08847, 24435, P30CA033572
Status last verified
Dec 2025
First submitted
4 Nov 2024
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Cannabidiol and Dronabinol in people with Breast Carcinoma and Chemotherapy-Induced Peripheral Neuropathy, run by City of Hope Medical Center 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 16 inclusion and 17 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 5 Dec 2025. 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjectively experienced symptoms of peripheral neuropathy (time frame: Up to 28 days after last dose of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731894.

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 5 Dec 2025.

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