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Phytocannabinoids for Reducing Chemotherapy-Induced Peripheral Neuropathy

This study is looking at how well different cannabis-based medicines, cannabidiol (CBD) and dronabinol (which contains THC and CBD), work to reduce chronic nerve damage (peripheral neuropathy) caused by chemotherapy. This nerve damage can cause pain, tingling, numbness, and muscle weakness. The study involves breast and colon cancer survivors who have experienced this type of nerve damage. You would be given either CBD, dronabinol, or a placebo (an inactive substance) by mouth. Researchers will measure your symptoms to see if these medicines help. The goal is to find out if these phytocannabinoids can effectively reduce your symptoms and improve your quality of life. The study plans to enroll 120 participants.

Study design
This is an interventional study that will randomly assign participants to receive one of three treatments. It plans to enroll 120 participants.
What's involved
You would provide a urine sample and complete surveys. The duration of participation is not specified, but primary symptoms are measured up to 28 days after the last dose.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured up to 28 days after your last dose of therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06731894

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
City of Hope Medical Center
~120 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCannabidiolDronabinolPlacebo AdministrationSurvey Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subjectively experienced symptoms of peripheral neuropathy
Measured over Up to 28 days after last dose of therapy

Conditions

Breast Carcinoma
Chemotherapy-Induced Peripheral Neuropathy
Colon Carcinoma

Explore related trials

Breast CarcinomaChemotherapy-Induced Peripheral NeuropathyColon Carcinoma

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Richard Lee · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Richard T. Lee
[email protected]
949-671-4091
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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)

Exclusion

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
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

What this trial measures

  • Subjectively experienced symptoms of peripheral neuropathyUp to 28 days after last dose of therapy

    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.