Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT05396820 - Adaptation of the Motor System to Experimental Pain N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Recruiting NCT06350084 - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05458037 - RCT of Pain Perception With Fast and Slow Tenaculum Application N/A
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Completed NCT06005480 - Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers Phase 1
Active, not recruiting NCT04850079 - EHR Precision Drug Treatment in Neonates
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Recruiting NCT05383820 - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment Phase 4
Completed NCT04851353 - Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures N/A
Completed NCT03280017 - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain Phase 4
Completed NCT04280796 - Changes in Affective Pain Processing in Human Volunteers N/A
Not yet recruiting NCT04523623 - Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries N/A
Not yet recruiting NCT04491630 - COping With PAin Through Hypnosis, Mindfulness and Spirituality N/A
Not yet recruiting NCT04062513 - Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response N/A
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Completed NCT04659395 - How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block N/A