Trial Outcomes & Findings for Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy (NCT NCT05388058)
NCT ID: NCT05388058
Last Updated: 2026-01-16
Results Overview
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.
COMPLETED
PHASE2
40 participants
Week 1, week 2, week 3, and week 4
2026-01-16
Participant Flow
Participant milestones
| Measure |
Arm I (Cannabidiol, Placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Initial Treatment
STARTED
|
20
|
20
|
|
Initial Treatment
COMPLETED
|
20
|
18
|
|
Initial Treatment
NOT COMPLETED
|
0
|
2
|
|
Crossover
STARTED
|
19
|
17
|
|
Crossover
COMPLETED
|
19
|
17
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Cannabidiol, Placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Initial Treatment
Withdrawal by Subject
|
0
|
1
|
|
Initial Treatment
Ineligible
|
0
|
1
|
Baseline Characteristics
Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Arm I (Cannabidiol, Placebo)
n=20 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.\> \> Cannabidiol: Applied topically\>
\> Placebo Administration: Applied topically\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=18 Participants
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.\> \> Cannabidiol: Applied topically\>
\> Placebo Administration: Applied topically\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 12.3 • n=9 Participants
|
61.3 years
STANDARD_DEVIATION 10.3 • n=6 Participants
|
62.9 years
STANDARD_DEVIATION 11.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
37 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Any Prior Cancer Therapy
|
20 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
38 Participants
n=9 Participants
|
|
Height (cm)
|
169.1 cm
STANDARD_DEVIATION 8.6 • n=9 Participants
|
170.8 cm
STANDARD_DEVIATION 8.6 • n=6 Participants
|
169.9 cm
STANDARD_DEVIATION 8.5 • n=9 Participants
|
|
Weight (Kg)
|
87.4 Kg
STANDARD_DEVIATION 17.1 • n=9 Participants
|
85.4 Kg
STANDARD_DEVIATION 14.8 • n=6 Participants
|
86.5 Kg
STANDARD_DEVIATION 15.9 • n=9 Participants
|
|
ECOG Performance Status
0
|
15 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
29 Participants
n=9 Participants
|
|
ECOG Performance Status
1
|
5 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
ECOG Performance Status
2
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
NCI-CTCAE v5.0 CIPN Grade
I
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
NCI-CTCAE v5.0 CIPN Grade
II
|
11 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
NCI-CTCAE v5.0 CIPN Grade
III
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
|
NCI-CTCAE v5.0 CIPN Grade
IV
|
5 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
NCI-CTCAE v5.0 CIPN Grade
Missing
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Week 1, week 2, week 3, and week 4CIPN 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.
Outcome measures
| Measure |
Arm I Crossover (Cannabidiol, Placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II Crossover (Placebo, Cannabidiol)
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.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (Cannabidiol, Placebo)
n=20 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=17 Participants
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline
Week 3
|
—
|
—
|
148.83 percentage of change in CIPN
Interval 113.66 to 184.0
|
140.33 percentage of change in CIPN
Interval 115.72 to 164.95
|
|
Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline
Week 1
|
—
|
—
|
147.95 percentage of change in CIPN
Interval 114.45 to 181.45
|
135.82 percentage of change in CIPN
Interval 116.34 to 155.3
|
|
Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline
Week 2
|
—
|
—
|
167.96 percentage of change in CIPN
Interval 106.64 to 229.28
|
148.45 percentage of change in CIPN
Interval 120.08 to 176.82
|
|
Change in Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline
Week 4
|
—
|
—
|
181.39 percentage of change in CIPN
Interval 100.69 to 262.1
|
142.72 percentage of change in CIPN
Interval 117.75 to 167.69
|
SECONDARY outcome
Timeframe: Week 1, week 2, week 3, and week 4Motor 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.
Outcome measures
| Measure |
Arm I Crossover (Cannabidiol, Placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II Crossover (Placebo, Cannabidiol)
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.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (Cannabidiol, Placebo)
n=20 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=17 Participants
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Change in EORTC QLQ CIPN20 Motor Subscale From Baseline
Week 1
|
—
|
—
|
129.79 percentage of change in EORTC
Interval 107.3 to 152.27
|
114.11 percentage of change in EORTC
Interval 99.34 to 128.89
|
|
Change in EORTC QLQ CIPN20 Motor Subscale From Baseline
Week 2
|
—
|
—
|
135.63 percentage of change in EORTC
Interval 108.05 to 163.21
|
131.13 percentage of change in EORTC
Interval 105.68 to 156.57
|
|
Change in EORTC QLQ CIPN20 Motor Subscale From Baseline
Week 3
|
—
|
—
|
126.09 percentage of change in EORTC
Interval 104.67 to 147.5
|
121.61 percentage of change in EORTC
Interval 103.249 to 139.974
|
|
Change in EORTC QLQ CIPN20 Motor Subscale From Baseline
Week 4
|
—
|
—
|
134.85 percentage of change in EORTC
Interval 107.531 to 162.158
|
123.26 percentage of change in EORTC
Interval 104.14 to 142.37
|
SECONDARY outcome
Timeframe: Week 1, week 2, week 3, and week 4Autonomic 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.
Outcome measures
| Measure |
Arm I Crossover (Cannabidiol, Placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II Crossover (Placebo, Cannabidiol)
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.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (Cannabidiol, Placebo)
n=20 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=17 Participants
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline
Week 1
|
—
|
—
|
110.88 percentage of change in EORTC
Interval 91.99 to 129.76
|
99.59 percentage of change in EORTC
Interval 91.59 to 107.58
|
|
Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline
Week 2
|
—
|
—
|
123.91 percentage of change in EORTC
Interval 106.78 to 141.04
|
100.85 percentage of change in EORTC
Interval 93.2 to 108.5
|
|
Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline
Week 3
|
—
|
—
|
112.07 percentage of change in EORTC
Interval 97.92 to 126.52
|
100.55 percentage of change in EORTC
Interval 89.93 to 111.17
|
|
Change in EORTC QLQ CIPN20 Autonomic Scale From Baseline
Week 4
|
—
|
—
|
120.71 percentage of change in EORTC
Interval 103.52 to 137.91
|
104.34 percentage of change in EORTC
Interval 95.3 to 113.37
|
SECONDARY outcome
Timeframe: Up to 14 days for each part of a sequenceIncidence of AEs will be reported per arm, assessed using Common Terminology Criteria (CTCAE) version 5.0.
Outcome measures
| Measure |
Arm I Crossover (Cannabidiol, Placebo)
n=19 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II Crossover (Placebo, Cannabidiol)
n=17 Participants
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.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (Cannabidiol, Placebo)
n=20 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=20 Participants
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Incidence of Adverse Events (AEs)
Hypotension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AEs)
Spinal fracture
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AEs)
Back pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysWill 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.
Outcome measures
| Measure |
Arm I Crossover (Cannabidiol, Placebo)
n=19 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II Crossover (Placebo, Cannabidiol)
n=17 Participants
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.
Cannabidiol: Applied topically
Placebo Administration: Applied topically
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (Cannabidiol, Placebo)
n=20 Participants
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=20 Participants
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.
\>
\> Cannabidiol: Applied topically
\>
\> Placebo Administration: Applied topically
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Incidence of Grade 3 or Higher Adverse Events
Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Grade 3 or Higher Adverse Events
Grade 4+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm I (Cannabidiol, Placebo)
Arm II (Placebo, Cannabidiol)
Arm I Crossover (Cannabidiol, Placebo)
Arm II Crossover (Placebo, Cannabidiol)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Cannabidiol, Placebo)
n=20 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Placebo, Cannabidiol)
n=20 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm I Crossover (Cannabidiol, Placebo)
n=19 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II Crossover (Placebo, Cannabidiol)
n=17 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Spinal fracture
|
5.0%
1/20 • Number of events 1 • Up to 28 days
|
0.00%
0/20 • Up to 28 days
|
0.00%
0/19 • Up to 28 days
|
0.00%
0/17 • Up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Up to 28 days
|
0.00%
0/20 • Up to 28 days
|
0.00%
0/19 • Up to 28 days
|
0.00%
0/17 • Up to 28 days
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Up to 28 days
|
0.00%
0/20 • Up to 28 days
|
0.00%
0/19 • Up to 28 days
|
0.00%
0/17 • Up to 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place