Recruiting

NEUROdouxLaser Photobiomodulation for Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy

What is being tested

Photobiomodulation sessions

Device

Who is being recruted

Over 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional

Study Start: October 2025

See protocol details

Summary

Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

Study ContactAurore MOUSSION

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 7, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on exploring a new method to help cancer patients who suffer from neuropathic pain caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). This condition often leads to sensations like numbness, pain, and tingling in a "gloves and socks" pattern on the body, impacting quality of life and sometimes necessitating changes in chemotherapy treatment. Traditional drug treatments offer limited relief, and there are currently no proven ways to prevent these painful side effects. This study investigates whether photobiomodulation (PBM), a type of light therapy, can effectively reduce these symptoms and improve patient well-being. Participants in this study will receive PBM treatment, which involves the use of non-ionizing laser light known for its healing and anti-inflammatory properties. This therapy is already used to prevent certain side effects of cancer treatment, but its effectiveness for CIPN is still being evaluated. The process is designed to be safe and aims to see if PBM can reduce the pain and discomfort associated with neuropathic pain in CIPN. The study will measure the effectiveness, practicality, and safety of PBM to determine if it can be a viable treatment option for those affected by this condition.

Official TitleEvaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy: a Randomized, Non-comparative, Placebo-controlled, Single-blinded, Phase II Clinical Trial in Cancer Patients

NCT06834685

Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

Study ContactAurore MOUSSION

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

Patient with a NP for at least 3 months after the end of an adjuvant or neo-adjuvant chemotherapy;

Patient having signed informed consent prior to any study procedure;

Effective contraception for women of childbearing age

Patient sufficiently fluent in French to complete questionnaires, as the investigator clinical discretion.

Show More Criteria

17 exclusion criteria prevent from participating

Patient using another concurrent non-pharmacological intervention or complementary therapy for neuropathy during the study;

Patient who has been already been treated with photobiomodulation on the area of interest.

Patient who has been treated with CAPSAISINE during the previous 3 months;

Patient with pacemaker;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Photobiomodulation sessions (2 per week for 4 weeks, 8 sessions in total) will be delivered by certified laser safety clinicians (i.e., algologists, pain nurses or neuropsychologists). The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm. The light will be applied to all hands and/or feet for 13 minutes. The order of transfer between feet and hands will be counterbalanced so that, half of the sessions will have started with feet, and the other half will have started with hands. The dose will be specified at each session. Patients will be treated in a sitting position (to treat the hands) or a semi-seated position (for feet). They will wear opaque glasses to ensure the safety of the laser and the blind condition of treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

ICM

Montpellier, FranceOpen ICM in Google Maps

Recruiting

One Study Center