Cannabidiol
Given PO
CBD · CBD Oil · Epidiolex · GWP42003-PLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-08-09
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
PRIMARY OBJECTIVE: I. Assess the ability of CBD and THC:CBD to reduce CIPN symptoms as compared to placebo using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale 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 Sccore - clinically based (TNSc), quantitative sensory testing (QST), Grooved Pegboard Test (GPT), 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: This is a dose-escalation study of CBD and THC. Patients are randomized to 1 of 3 arms. ARM I: Patients receive CBD orally (PO) on study. ARM II: Patients receive CBD PO + THC PO on study. ARM III: Patients receive placebo PO on study.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Given PO
CBD · CBD Oil · Epidiolex · GWP42003-PGiven PO
.DELTA.8-TETRAHYDROCANNABINOL · delta-8-THCGiven PO
Ancillary studies
Eligibility
primary outcomes
Time frame: Baseline up to week 12
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.
secondary outcomes
Time frame: Up to 12 weeks
The pre-treatment values recorded from the FACT-G will be considered the baseline scores. 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 12 weeks
Medication data will initially be analyzed as a dichotomous variable (yes/no) for each medication. These medications may include neuropathic medications (e.g., gabapentin, pregabalin, duloxetine, amitriptyline), Non-steroidal anti-inflammatory drugs, acetaminophen, opioid medications (e.g., morphine, oxycodone), or other related medications. 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. The usage of multiple medications will be summarized descriptively to determine the best way to quantify multiple use, such as counts or categorized quantities. McNemar's test will be used to detect change in the level of medication use.
Time frame: Up to 12 weeks
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.
Publications
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