Trial Outcomes & Findings for Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN (NCT NCT03206216)

NCT ID: NCT03206216

Last Updated: 2018-12-19

Results Overview

The "A-delta:C pain threshold ratio" is calculated based on the A-delta-fiber and C-fiber pain thresholds. The outcome was the difference in the A-delta:C pain ratio between the 9-week assessment and the 21-week assessment, to be reported as the mean with standard deviation for participant with painful CIPN (Group A) or painless CIPN (Group B).

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Group A - Painful CIPN Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation. Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation	Group B - Painless CIPN Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation. Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A - Painful CIPN Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation. Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation	Group B - Painless CIPN Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation. Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: The only participant withdrew before the 21-week assessment. No outcome assessment is possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: The only participant withdrew before the 21-week assessment. No outcome assessment is possible.

A Spearman correlation coefficient will be obtained for the A-delta:C pain threshold ratio as measured at 9 weeks (dependent variable) assessed against the presence or absence of pain (binary pain value) at 21 weeks (independent variable). The Spearman correlation coefficient will be obtained by logistic regression analysis.

Outcome measures

Outcome data not reported

Adverse Events

Group A - Painful CIPN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B - Painless CIPN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Seema Nagpal, MD

Stanford University Medical Center

Phone: 650-725-8630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group A - Painful CIPN Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation. Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation	Group B - Painless CIPN n=1 Participants Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy. A questionnaire is used to assess the level of pain after stimulation. Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants