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

NCT06731894 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 24435NCI-2024-08847P30CA033572
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Breast Carcinoma; Chemotherapy-Induced Peripheral Neuropathy; Colon Carcinoma

Outcome Measures

Primary Outcomes (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.

  Up to 28 days after last dose of therapy

Secondary Outcomes (4)

• Health-related quality of life

  Up to 28 days after last dose of therapy

• Neuropathic medication utilization

  Up to 28 days after last dose of therapy

• Pain medication utilization

  Up to 28 days after last dose of therapy

• Incidence of adverse events

  Up to 28 days after last dose of therapy

Study Arms (3)

Arm I (CBD)

EXPERIMENTAL

Patients 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.

Procedure: Biospecimen Collection; Drug: Cannabidiol; Other: Survey Administration

Arm II (THC:CBD)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Cannabidiol; Drug: Dronabinol; Drug: Placebo Administration; Other: Survey Administration

Arm III (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (CBD); Arm II (THC:CBD); Arm III (placebo)

Cannabidiol DRUG

Given PO

Also known as: CBD, CBD Oil, Epidiolex, GWP42003-P

Arm I (CBD); Arm II (THC:CBD)

Dronabinol DRUG

Given PO

Also known as: (-)-.DELTA.9-Tetrahydrocannabinol, Abbott 40566, Delta(9)-Tetrahydrocannibinol, Delta-9-Tetrahydrocannabinol, Delta-9-THC, Delta9-THC, Marinol, SP 104, SP-104, SYNDROS, Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol, Tetrahydrocannabinol, THC

Arm II (THC:CBD)

Placebo Administration DRUG

Given PO

Arm II (THC:CBD); Arm III (placebo)

Survey Administration OTHER

Ancillary studies

Arm I (CBD); Arm II (THC:CBD); Arm III (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Interventions

Specimen Handling; Cannabidiol; Dronabinol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Richard Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Every bottle will be labelled in a blinded fashion. IDS Pharmacy will obtain the unblinded key. The study team, including the physician, will remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 13, 2024
• Study Start: October 3, 2025
• Primary Completion (Estimated): January 7, 2028
• Study Completion (Estimated): January 7, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (2)