Trial Outcomes & Findings for Cannabinoids for Taxane Induced Peripheral Neuropathy (NCT NCT03782402)
NCT ID: NCT03782402
Last Updated: 2023-01-26
Results Overview
This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10
TERMINATED
PHASE2
12 participants
value at the later time (8 weeks) point minus the value at the earlier time point (baseline)
2023-01-26
Participant Flow
Participants were assigned based on history of cannabis use.
Participant milestones
| Measure |
Cannabinoids (THC and CBD)
Cannabinoids with THC and CBD, titrated to a maximum of 15 mg THC, 300 mg CBD
|
Placebo Cannabinoids
Placebo cannabinoids for comparison
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cannabinoids for Taxane Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Cannabinoids (THC and CBD)
n=6 Participants
Cannabinoids THC and CBD titrated
|
Placebo Cannabinoids
n=6 Participants
placebo cannabinoids for comparison
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8 • n=99 Participants
|
54 years
STANDARD_DEVIATION 8 • n=107 Participants
|
54 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: value at the later time (8 weeks) point minus the value at the earlier time point (baseline)This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10
Outcome measures
| Measure |
Cannabinoids (THC Ans CBD)
n=6 Participants
Cannabinoids with different concentrations of THC and CBD
|
Placebo Cannabinoids
n=6 Participants
Placebo with no THC to CBD
|
|---|---|---|
|
Brief Pain Inventory-Short Form (BPI)
|
4.8 units on a scale
Standard Deviation 1.5
|
5.8 units on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and weekly until end of study.Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Baseline and weekly until end of studyOutcome measures
Outcome data not reported
Adverse Events
Cannabinoids (THC and CBD)
Placebo Cannabinoids
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabinoids (THC and CBD)
n=6 participants at risk
Strengths of cannabinoids will vary across groups
Cannabinoids: Cannabinoids with different concentrations of THC and CBD
|
Placebo Cannabinoids
n=6 participants at risk
Strengths of cannabinoids will vary across groups
Cannabinoids: Cannabinoids with different concentrations of THC and CBD
|
|---|---|---|
|
Nervous system disorders
Sedation
|
33.3%
2/6 • Adverse events were collected over 8 weeks.
No participants were expected to ne at risk for all-cause mortality.
|
33.3%
2/6 • Adverse events were collected over 8 weeks.
No participants were expected to ne at risk for all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place