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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Week 1, week 2, week 3, and week 4

Results posted on

2026-01-16

Participant Flow

Participant milestones

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 sequence

Incidence of AEs will be reported per arm, assessed using Common Terminology Criteria (CTCAE) version 5.0.

Outcome measures

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 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.

Outcome measures

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)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Arm II (Placebo, Cannabidiol)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm I Crossover (Cannabidiol, Placebo)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm II Crossover (Placebo, Cannabidiol)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Stacy D. D'Andre

Mayo Clinic

Phone: 507-284-2511

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place