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

Pain, Acute Clinical Trial

Official title: Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN

Status Terminated

Clinical Trial Summary

This clinical trial studies how well Diode laser fiber type Selective Stimulator (DLss) works in predicting pain development in patients with ovarian cancer who are receiving chemotherapy. Stimulating of the pain nerve fibers in the skin with laser light stimulation may help to predict whether a patient will develop painful peripheral neuropathy, correlate with the severity of neuropathy during and after chemotherapy treatment, and may help to explain the mechanisms of chemotherapy-induced neuropathic pain (CIPN).

Clinical Trial Description

Laser stimulation, similar to what is being used in the DLss, has been used in pain clinics and research since 1975 as a diagnostic test for pain sensitivity. It is widely considered to be both useful and safe. Laser irradiation /stimulation simultaneously can activate either the heat-sensitive A-delta or C never fibers, with the difference in affected nerves being primarily on the basis of different pulse duration and different diameter of the simulation target. The laser for both type of simulation is set to 980 nanometers.

Laser irradiation intensity is measured as the milli-amperes (mA) required to generate that laser intensity. The pain sensitively of A-delta and C fibers are assessed by specific protocols (A-delta protocol: 60 millisecond duration, 980 nm stimuli, 1 mm diameter simulation target. C protocol: 2 second duration, 5 mm diameter simulation target).

Pain sensitivity is assessed as the ratio of painful laser intensity between the A-delta and C fibers (A-delta:C pain ratio).

Participants with ovarian cancer, with either painful (Group A) or painless (Group B) chemotherapy-induced peripheral neuropathy (CIPN), were to be assessed for pain sensitivity after 9 and 21 weeks of chemotherapy with Diode Laser fiber type Selective Stimulator (DLss). Both painful or painless CIPN are undesirable chemotherapy-induced side effects. The same testing protocol was used for these groups (ie, any difference between the groups would be attributed to differences in pain sensitivity between the groups). Patients would report the stimulation on a 0 to 100 scale, with 0 = no sensation; 10 = definite sensation; 0 to 40 = "painful"; and 100 = worst imaginable pain.

PRIMARY OBJECTIVES:

• Determine if there is a difference in the A-delta:C pain threshold ratio for patients with painful chemotherapy-induced peripheral neuropathy (CIPN) compared to patients with painless CIPN.

• Determine the A-delta:C ratio over time in patients with CIPN. ;

Related Conditions & MeSH terms

• Acute Pain
• Burning Pain
• Impaired Balance
• Malignant Ovarian Neoplasm
• Numbness
• Ovarian Neoplasms
• Pain
• Pain, Acute
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Tingling

• NCT number: NCT03206216
• Study type: Interventional
• Source: Stanford University
• Status: Terminated
• Phase: N/A
• Start date: August 4, 2017
• Completion date: October 30, 2017