Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

January 9, 2024 updated by: Saint-Gregoire Private Hospital Center
Peripheral neuropathy is one of the most common side effects of oxaliplatin (OXA)-based chemotherapy for patients treated for digestive cancers, disabling and dose-limiting. Several strategies have been studied for the treatment of oxaliplatin-related sensory neuropathy. Several pharmacological and non-pharmacological therapeutic strategies have been explored to relieve peripheral neuropathic pain. Non-pharmacological interventions have been shown to be potentially beneficial for patients suffering from chemotherapy-induced neurotoxicity. The objective of this prospective study is to evaluate the effectiveness of photobiomodulation on the reduction of neuropathic pain in patients who developed painful, cumulative peripheral neuropathy that appeared under the effect of the treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Grégoire, France, 35700
        • Recruiting
        • CHP Saint-Gregoire
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recent diagnosis of digestive cancer
  • 12 planned cycles of oxaliplatin
  • Ability to understand and willingness to sign an informed consent form before starting any study procedures
  • Patient benefiting from French health insurance

Exclusion Criteria:

  • History of neuropathy before the start of the study,
  • Symptomatic treatment of pain (or neuropathic pain),
  • Patient with a psychotic disorder,
  • Patient with diabetic neuropathy,
  • Patient with metastatic cancer
  • Patient with renal insufficiency,
  • Adults under guardianship or curatorship,
  • Vulnerable people

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients will not receive any intervention during their oxaliplatin chemotherapy cycles.
Experimental: Experimental
Patients will receive three photobiomodulation sessions per week during their oxaliplatin chemotherapy cycles
Procedure: Photobiomodulation

In oncology, photobiomodulation is used to help heal damaged tissues, improve immune response, reduce inflammation, and prevent or treat certain side effects of treatments such as chemotherapy. Photobiomodulation is also the subject of recent clinical studies to expand its indications (peripheral neuropathies induced by certain chemotherapies.

Patients in the experimental group will receive 3 photobiomodulation sessions per week during their oxaliplatin treatments (6 months), for a total of 72 sessions. Exposition to laser light is 30 minutes for each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Synptom Inventory : pain
Time Frame: day 30, day 60, day 90, day 120, day 150, day 180, day 270
Is is a score with 12 items. 10 items concern pain and are scale from 0 (no pain) to 10 (maximal pain).
day 30, day 60, day 90, day 120, day 150, day 180, day 270

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-relative quality of life of cancer patients participating to a clinical trial
Time Frame: day 0, day 60, day 120, day 180, day 270
QLQ-C30 EORTC scale : 30 items scored from 1 (not at all) to 4 (very). Global health status, functional scales and symptom scales are reported.
day 0, day 60, day 120, day 180, day 270
Peripheral neuropathy : SUDOSCAN evaluation
Time Frame: day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270
Evaluation of peripheral neuropathy by SUDOSCAN (detection and evaluation of small fiber neuropathies)
day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270
Peripheral neuropathy : electroneuromyogram evaluation
Time Frame: day 0, day 90, day 270
Evaluation by electroneuromyogram : measurement of nerve conduction velocity
day 0, day 90, day 270
Evaluation of sensitive and motor symptoms
Time Frame: day 30, day 60, day 90, day 120, day 150, day 180, day 270
TNSc score : 7 items to explore sensitive and motor symptoms, scored from 0 (no symptom) from 4 (very important symptoms)
day 30, day 60, day 90, day 120, day 150, day 180, day 270

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Gregoire Private Hospital Center

Investigators

  • Principal Investigator: Morgane Pihan, CHP Saint-Gregoire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurosudoscan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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