Phytocannabinoids to reduce chronic chemotherapy-related nerve pain in breast and colon cancer survivors
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
This will test whether daily CBD or a combined THC:CBD treatment can reduce long-term nerve pain, tingling, and numbness in people who survived breast or colon cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Duarte, California and 1 other locations) |
| Trial ID | NCT06731894 on ClinicalTrials.gov |
What this trial studies
This is a phase II, randomized, placebo-controlled trial comparing oral cannabidiol (CBD), a THC:CBD formulation, and placebo in breast and colon cancer survivors with chronic chemotherapy-induced peripheral neuropathy (CIPN). Participants are randomly assigned to one of three arms with a defined dosing escalation in the first cycle and continued dosing thereafter. The primary outcome is change in the FACT/GOG-Ntx neuropathy score, with secondary outcomes including overall quality of life (FACT-G), use of other neuropathic and pain medications, and safety. Exploratory measures include objective neurologic tests such as the Total Neuropathy Score-clinical (TNSc), Quantitative Sensory Testing (QST), gait and balance tests, and analysis of predictors of response.
Who should consider this trial
Good fit: Adults (≥18) who survived breast or colon cancer, completed taxane or platinum chemotherapy, have persistent CIPN meeting the trial's neuropathy score requirements, have ECOG ≤2, and are willing to use medical cannabis and attend study visits are ideal candidates.
Not a fit: Patients whose neuropathy is not related to prior taxane/platinum chemotherapy, who cannot tolerate cannabinoids, or who have conditions or medications that contraindicate THC/CBD use are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer survivors an effective, non-opioid option to reduce chronic chemotherapy-related nerve pain and improve daily functioning.
How similar studies have performed: Some prior research suggests cannabinoids can help chronic pain, but high-quality evidence specifically showing benefit for chemotherapy-induced peripheral neuropathy is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Duarte, California and 1 other locations
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- City of Hope at Irvine Lennar — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Richard Lee — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.