Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

NCT05672342 | Withdrawn Early Phase 1 DMC FDA Drug

• 4 other identifiers: 22339NCI-2022-10253P30CA033572R21CA260447
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests how well phytocannabinoids (cannabidiol \[CBD\] and tetrahydrocannbinol \[THC\]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.

Conditions

Breast Carcinoma; Chemotherapy-Induced Peripheral Neuropathy; Colon Carcinoma

Outcome Measures

Primary Outcomes (1)

• Difference in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores

  The primary analysis will compare difference in scores from the FACT/GOG-Ntx between all groups using analysis of variance, and a repeated measures analysis of variance analysis will be performed. Multivariable mixed-effects regression model which takes possible dependence of longitudinal measurements within each subject into account, will be used. In addition, a paired t-test will be utilized to compare scores between baseline and 8 and 12 weeks of treatment for each group separately.

  Baseline up to week 12

Secondary Outcomes (3)

• Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G) scores

  Up to 12 weeks

• Utilization of neuropathic and pain medications

  Up to 12 weeks

• Incidents of adverse events

  Up to 12 weeks

Study Arms (3)

Arm I (CBD)

EXPERIMENTAL

Patients receive CBD PO on study.

Drug: Cannabidiol; Other: Questionnaire Administration

Arm II (CBD + THC)

EXPERIMENTAL

Patients receive CBD PO + THC PO on study.

Drug: Cannabidiol; Drug: Delta-8-Tetrahydrocannabinol; Other: Questionnaire Administration

Arm III (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO on study.

Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Cannabidiol DRUG

Given PO

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

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

Delta-8-Tetrahydrocannabinol DRUG

Given PO

Also known as: .DELTA.8-TETRAHYDROCANNABINOL, delta-8-THC

Arm II (CBD + THC)

Placebo Administration DRUG

Given PO

Arm III (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (CBD); Arm II (CBD + THC); 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 (ECOG) =\< 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 limit of normal (ULN) (unless has Gilbert's disease)
• Aspartate aminotransferase (AST) =\< 3 x ULN
• Alanine aminotransferase (ALT) =\< 3 x ULN
• 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
• 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:

• 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 human immunodeficiency virus (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.
• Note: 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)

Sponsors & Collaborators

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

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Interventions

Cannabidiol; delta-8-tetrahydrocannabinol

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)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Richard T Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: July 6, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)