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

Summary

The investigators propose that using the Diode Laser fiber type Selective Stimulator (DLss) in patients with chemotherapy-induced peripheral neuropathy (CIPN) will allow for the assessment of changes in small-fiber pain thresholds, to identify differences between subjects who received chemotherapy and developed painful CIPN, compared to subjects who received similar chemotherapy but did not develop painful CIPN (control group).

Additionally, the investigators would like to investigate whether the response to DLss correlates with pain severity in patients with persistent painful neuropathy.

The ultimate goal of this study is to develop a non-invasive, bedside quantitative test that is specific for painful CIPN. If the investigators' initial hypothesis is confirmed, the next step would be to design a prospective longitudinal study and assess changes in DLss early after initiation of chemotherapy, to determine whether this approach can help identify early predictive parameters of painful CIPN.

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".

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Lasmed LLC

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Simon Haroutounian, Ph.D. · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-17

Primary Completion

2019-09-17

Completion

2019-09-17

Countries

• United States

Study Locations