Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVE:
I. 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:
I. 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:
I. 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Medical Center
-
Contact:
- Richard T. Lee
- Phone Number: 949-671-4091
- Email: RichLee@coh.org
-
Principal Investigator:
- Richard Lee
-
Irvine, California, United States, 92618
- Recruiting
- City of Hope at Irvine Lennar
-
Principal Investigator:
- Richard Lee
-
Contact:
- Richard Lee
- Phone Number: 949-671-4091
- Email: richlee@coh.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (CBD)
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.
|
Ancillary studies
Given PO
Other Names:
Undergo urine sample collection
Other Names:
|
|
Experimental: Arm II (THC:CBD)
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.
|
Ancillary studies
Given PO
Given PO
Other Names:
Undergo urine sample collection
Other Names:
Given PO
Other Names:
|
|
Placebo Comparator: Arm III (placebo)
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.
|
Ancillary studies
Given PO
Undergo urine sample collection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjectively experienced symptoms of peripheral neuropathy
Time Frame: Up 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.
|
Up to 28 days after last dose of therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: Up to 28 days after last dose of therapy
|
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.
|
Up to 28 days after last dose of therapy
|
|
Neuropathic medication utilization
Time Frame: Up to 28 days after last dose of therapy
|
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.
|
Up to 28 days after last dose of therapy
|
|
Pain medication utilization
Time Frame: Up to 28 days after last dose of therapy
|
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.
|
Up to 28 days after last dose of therapy
|
|
Incidence of adverse events
Time Frame: Up to 28 days after last dose of therapy
|
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.
|
Up to 28 days after last dose of therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Lee, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Colonic Neoplasms
- Breast Neoplasms
- Organic Chemicals
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Hydrocarbons
- Terpenes
- Cannabinoids
- Cannabidiol
- Dronabinol
- Specimen Handling
Other Study ID Numbers
- 24435 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2024-08847 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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