Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo urine sample collection
Cannabidiol
DrugGiven PO
Dronabinol
DrugGiven PO
Placebo Administration
DrugGiven PO
Survey Administration
Other interventionAncillary studies
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Arm I (CBD)Experimental treatment 3 interventions
Group B: Arm II (THC:CBD)Experimental treatment 5 interventions
Group C: Arm III (placebo)Placebo comparator 3 interventions
Trial outcomes
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.
Time frame
Up to 28 days after last dose of therapySecondary outcomes
1
Health-related quality of life
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.
Time frame
Up to 28 days after last dose of therapy2
Neuropathic medication utilization
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.
Time frame
Up to 28 days after last dose of therapy3
Pain medication utilization
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.
Time frame
Up to 28 days after last dose of therapy4
Incidence of adverse events
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.
Time frame
Up to 28 days after last dose of therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov