A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)

NACompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 17, 2018

Primary Completion Date

September 17, 2019

Study Completion Date

September 17, 2019

Conditions
Chemotherapy-induced Peripheral Neuropathy
Interventions
OTHER

Brief Pain Inventory

-A self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity (4 items which generate the PAIN SEVERITY score), list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life (7 items which generate the PAIN INTERFERENCE score) on a 10 point scale.

OTHER

Hospital Anxiety and Depression Scale

"* 14 item scale with even of the items relating to anxiety and seven relating to depression~* Each item on the questionnaire is scored from 0-3 and this means that a patient can score between 0 and 21 for either anxiety or depression"

OTHER

Neuropathic Pain Symptom Inventory

-The NPSI questionnaire utilized in this study includes eight parameters (i.e., burning pain, squeezing pain, pressure pain, electric shock pain, stabbing pain, tingling pain, pins and needles pain and allodynia \[pain provoked by light touch\]). Each of the parameters includes recall of the past 24 hours

PROCEDURE

Diode Laser fiber type Selective Stimulator

"-Each patient will have an A and C fiber stimulation. Stimulation will be performed on the dorsum of the foot using stimulation previously published parameters to elicit burning pain, which is from activation of C-fibers and pinprick pain from A-fibers"

PROCEDURE

Quantitative sensory testing

"* Quantitative sensory testing will be performed on the dorsal mid-foot and the ipsilateral shoulder will serve as control area~* Cold and warm detection thresholds, cold and heat pain thresholds, mechanical detection thresholds, and wind-up ratio"

PROCEDURE

Conditioned pain modulation efficiency

-Immersion of a hand up to the wrist to a thermostat-controlled water bath maintained at 12 degrees Celsius, and the application of a heat stimulus on the contralateral forearm.

OTHER

Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS)

"-The subjects are asked to rate the intensity of their current pain on a 0-10 scale - 0 denoting no pain and 10 denoting worst imaginable pain."

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Lasmed LLC

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Washington University School of Medicine

OTHER

NCT03687970 - A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN) | Biotech Hunter | Biotech Hunter