Cannabidiol
Applied topically
CBD · CBD Oil · Epidiolex · GWP42003-PLoading study record…
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This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy caused by chemotherapy is called chemotherapy-induced peripheral neuropathy (CIPN). CIPN is commonly seen in patients receiving certain chemotherapy medications and is hard to treat. Medications commonly used to treat CIPN have limited benefits and may cause significant side effects. A small report showed that topical cannabidiol may help treat neuropathy in patients with diabetes. This study is being done to determine if cannabidiol cream can help improve the symptoms of CIPN.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-01-16
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
PRIMARY OBJECTIVES: I. To evaluate whether topical cannabidiol (CBD) improves CIPN, compared to placebo. II. To evaluate side effects from topical CBD cream use, compared to placebo. SECONDARY OBJECTIVES: I. Other measures of neuropathy as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN20 motor subscale, the EORTC QLQ CIPN20 autonomic scale, and the total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale. II. Adverse event profiles will also be assessed using symptom questionnaires and CTCAE version (v)5.0. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply cannabidiol cream topically to affected areas twice daily (BID) for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days. ARM II: Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Applied topically
CBD · CBD Oil · Epidiolex · GWP42003-PApplied topically
Ancillary studies
Quality of Life AssessmentAncillary studies
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
CIPN will be measured by the sensory subscale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 which is composed of 9 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Arm I (Cannabidiol, Placebo) | 20 | 147.95 | 114.45 to 181.45 |
| Arm II (Placebo, Cannabidiol) | 17 | 135.82 | 116.34 to 155.30 |
| Arm I (Cannabidiol, Placebo) | 20 | 167.96 | 106.64 to 229.28 |
| Arm II (Placebo, Cannabidiol) | 17 | 148.45 | 120.08 to 176.82 |
| Arm I (Cannabidiol, Placebo) | 20 | 148.83 | 113.66 to 184.00 |
| Arm II (Placebo, Cannabidiol) | 17 | 140.33 | 115.72 to 164.95 |
| Arm I (Cannabidiol, Placebo) | 20 | 181.39 | 100.69 to 262.10 |
| Arm II (Placebo, Cannabidiol) | 17 | 142.72 | 117.75 to 167.69 |
Motor symptoms of CIPN will be measured by the motor subscale of the EEORTC QLQ-CIPN20 which is composed of 8 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Arm I (Cannabidiol, Placebo) | 20 | 129.79 | 107.30 to 152.27 |
| Arm II (Placebo, Cannabidiol) | 17 | 114.11 | 99.34 to 128.89 |
| Arm I (Cannabidiol, Placebo) | 20 | 135.63 | 108.05 to 163.21 |
| Arm II (Placebo, Cannabidiol) | 17 | 131.13 | 105.68 to 156.57 |
| Arm I (Cannabidiol, Placebo) | 20 | 126.09 | 104.67 to 147.50 |
| Arm II (Placebo, Cannabidiol) | 17 | 121.61 | 103.249 to 139.974 |
| Arm I (Cannabidiol, Placebo) | 20 | 134.85 | 107.531 to 162.158 |
| Arm II (Placebo, Cannabidiol) | 17 | 123.26 | 104.14 to 142.37 |
Autonomic nervous system symptoms related to CIPN will be measured by the autonomic subscale of the EEORTC QLQ-CIPN20 which is composed of 3 individual items answered on a 4-point scale ranging from "not at all' to "very much." . Higher scores indicate more severe symptoms. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Arm I (Cannabidiol, Placebo) | 20 | 110.88 | 91.99 to 129.76 |
| Arm II (Placebo, Cannabidiol) | 17 | 99.59 | 91.59 to 107.58 |
| Arm I (Cannabidiol, Placebo) | 20 | 123.91 | 106.78 to 141.04 |
| Arm II (Placebo, Cannabidiol) | 17 | 100.85 | 93.20 to 108.50 |
| Arm I (Cannabidiol, Placebo) | 20 | 112.07 | 97.92 to 126.52 |
| Arm II (Placebo, Cannabidiol) | 17 | 100.55 | 89.93 to 111.17 |
| Arm I (Cannabidiol, Placebo) | 20 | 120.71 | 103.52 to 137.91 |
| Arm II (Placebo, Cannabidiol) | 17 | 104.34 | 95.30 to 113.37 |
Incidence of AEs will be reported per arm, assessed using Common Terminology Criteria (CTCAE) version 5.0.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Arm I (Cannabidiol, Placebo) | 20 | 1 | - |
| Arm II (Placebo, Cannabidiol) | 20 | 0 | - |
| Arm I Crossover (Cannabidiol, Placebo) | 19 | 0 | - |
| Arm II Crossover (Placebo, Cannabidiol) | 17 | 0 | - |
| Arm I (Cannabidiol, Placebo) | 20 | 1 | - |
| Arm II (Placebo, Cannabidiol) | 20 | 0 | - |
| Arm I Crossover (Cannabidiol, Placebo) | 19 | 0 | - |
| Arm II Crossover (Placebo, Cannabidiol) | 17 | 0 | - |
| Arm I (Cannabidiol, Placebo) | 20 | 1 | - |
| Arm II (Placebo, Cannabidiol) | 20 | 0 | - |
| Arm I Crossover (Cannabidiol, Placebo) | 19 | 0 | - |
| Arm II Crossover (Placebo, Cannabidiol) | 17 | 0 | - |
Will be assessed using symptom questionnaires and CTCAE version 5.0. Will compare the maximum (worst) values between arms. Fisher's exact tests will be used to compare incidence rates and Wilcoxon rank-sum tests will be used to compare maximum values between arms.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Arm I (Cannabidiol, Placebo) | 20 | 2 | - |
| Arm II (Placebo, Cannabidiol) | 20 | 0 | - |
| Arm I Crossover (Cannabidiol, Placebo) | 19 | 0 | - |
| Arm II Crossover (Placebo, Cannabidiol) | 17 | 0 | - |
| Arm I (Cannabidiol, Placebo) | 20 | 0 | - |
| Arm II (Placebo, Cannabidiol) | 20 | 0 | - |
| Arm I Crossover (Cannabidiol, Placebo) | 19 | 0 | - |
| Arm II Crossover (Placebo, Cannabidiol) | 17 | 0 | - |
| Milestone | Arm I (Cannabidiol, Placebo) | Arm II (Placebo, Cannabidiol) |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 20 | 18 |
| NOT COMPLETED | 0 | 2 |
| Milestone | Arm I (Cannabidiol, Placebo) | Arm II (Placebo, Cannabidiol) |
|---|---|---|
| STARTED | 19 | 17 |
| COMPLETED | 19 | 17 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Spinal fracture | Injury, poisoning and procedural complications | Arm I (Cannabidiol, Placebo): 1 / 20 · Arm II (Placebo, Cannabidiol): 0 / 20 · Arm I Crossover (Cannabidiol, Placebo): 0 / 19 · Arm II Crossover (Placebo, Cannabidiol): 0 / 17 |
| Back pain | Musculoskeletal and connective tissue disorders | Arm I (Cannabidiol, Placebo): 1 / 20 · Arm II (Placebo, Cannabidiol): 0 / 20 · Arm I Crossover (Cannabidiol, Placebo): 0 / 19 · Arm II Crossover (Placebo, Cannabidiol): 0 / 17 |
| Hypotension | Vascular disorders | Arm I (Cannabidiol, Placebo): 1 / 20 · Arm II (Placebo, Cannabidiol): 0 / 20 · Arm I Crossover (Cannabidiol, Placebo): 0 / 19 · Arm II Crossover (Placebo, Cannabidiol): 0 / 17 |
Eligibility
primary outcomes
Time frame: Week 1, week 2, week 3, and week 4
CIPN will be measured by the sensory subscale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 which is composed of 9 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms.
secondary outcomes
Time frame: Week 1, week 2, week 3, and week 4
Motor symptoms of CIPN will be measured by the motor subscale of the EEORTC QLQ-CIPN20 which is composed of 8 individual items. Each item is scored on a 1-to-4 scale, where 1 means "not at all" and 4 means "very much." Higher scores indicate greater severity of symptoms. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.
Time frame: Week 1, week 2, week 3, and week 4
Autonomic nervous system symptoms related to CIPN will be measured by the autonomic subscale of the EEORTC QLQ-CIPN20 which is composed of 3 individual items answered on a 4-point scale ranging from "not at all' to "very much." . Higher scores indicate more severe symptoms. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.
Time frame: Up to 14 days for each part of a sequence
Incidence of AEs will be reported per arm, assessed using Common Terminology Criteria (CTCAE) version 5.0.
Time frame: Up to 28 days
Will be assessed using symptom questionnaires and CTCAE version 5.0. Will compare the maximum (worst) values between arms. Fisher's exact tests will be used to compare incidence rates and Wilcoxon rank-sum tests will be used to compare maximum values between arms.
Publications
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