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

Not Applicable

Terminated

Conditions: Malignant Ovarian Neoplasm
Numbness
Tingling
Impaired Balance
Peripheral Neuropathy
Pain, Acute
Burning Pain

Interventions: Diagnostic Test: Diode Laser fiber type Selective Stimulator (DLss)

Registration Number: NCT03206216

Lead Sponsor: Stanford University

Brief 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).

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group B - Painless CIPN	Diode Laser fiber type Selective Stimulator (DLss)	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.
Group A - Painful CIPN	Diode Laser fiber type Selective Stimulator (DLss)	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.

Primary Outcome Measures

Name	Time	Method
A-delta:C Pain Threshold Ratio	Up to 24 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Correlation Between the "Adelta:C Pain Threshold Ratio" and Pain Development	Up to 24 weeks	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.