Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients (NEUROdoux)

June 2, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Evaluating 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

Chemotherapy-induced peripheral neuropathy (CIPN) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Symptoms associated with CIPN are usually symmetric and bilateral (typical distribution in "gloves and socks") inducing sensory alterations, paresthesias, dysesthesias, numbness and pain. Neuropathic Pain (NP) is an important characteristic of CIPN, affects 25-80% of patients with CIPN, and reduces quality of life (e.g., concomitant psychological distress, risks of falls, risks of neurocognitive impairments, and sleep disorders).

In severe cases, it is even necessary to delay and/or reduce the dose of chemotherapy. The benefit of drug interventions on NP remains limited. To date, there are no proven preventive strategies and few evidence-based treatment options for CIPN. Also, the use of complementary or non-pharmacological interventions are common, including photobiomodulation (PBM).

PBM is the therapeutic use of non-ionizing laser light for its anti-inflammatory and regenerative effects. Its use is currently recommended only for the prevention of oral mucositis related to cancer treatments. Recent preliminary clinical evidence suggests that PBM may be beneficial to established CIPN, with safety and improvement beyond the intervention. However, to date, clinical trials are rare, have methodological weaknesses, and/or focus on global CIPN. The overall objectives of the study are therefore to assess the effectiveness, feasibility and safety of the PBM for treating NP in the CIPN.

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

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:

  • Male or female aged 18 years minimum;
  • Patient treated at the Montpellier Cancer Institute for a cancer (whatever the location) requiring a chemotherapy;
  • Patient with significant NP defined as a score of 4 at the clinician-rated DN4 ;
  • Patient with a NP for at least 3 months after the end of an adjuvant or neo-adjuvant chemotherapy;
  • Women of childbearing potential must have a pregnancy urinary test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy);
  • Effective contraception for women of childbearing age
  • Patient having signed informed consent prior to any study procedure;
  • Patient affiliated to a French social protection system;
  • Patient sufficiently fluent in French to complete questionnaires, as the investigator clinical discretion.

Exclusion Criteria:

  • Patient unable to come twice a week to the Montpellier Cancer Institute;
  • Patient unable to sit for a 30-minutes period;
  • Patient with an open wound or ulcer on the treatment area;
  • Patient whose diagnosis of peripheral neuropathy is due to another cause (n.b., diabetes without neuropathy will not be a specific exclusion);
  • Patient with uncontrolled psychiatric illness or neurocognitive impairment that may interfere with assessments, as the investigator clinical discretion;
  • Patient whose estimated life expectancy is less than 3 months, as estimated by a clinical investigator;
  • Patient using another concurrent non-pharmacological intervention or complementary therapy for neuropathy during the study;
  • Patient who has been treated with CAPSAISINE during the previous 3 months;
  • Patient with pacemaker;
  • Epileptic patient;
  • Patient with photosensitive medications, or any medical condition causing sensitivity to light (n.b., Lupus);
  • Pregnant and/or breastfeeding woman;
  • Patient with primary tumor and/or metastases in areas to be treated by BPM (i.e., hands and/or feet);
  • Patient with pre-existing eye disease (such as maculopathy, glaucoma, cataract and retinal lesions), or a history of family eye diseases;
  • Patient who has been already been treated with photobiomodulation on the area of interest.
  • Participation in another concomitant clinical study with neuropathic pain or chemo-induced peripheral neuropathy as the primary endpoint.
  • Presence of a tattoo on the area to be treated.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm

In the sham therapy, patients will have the same procedure as the laser intervention (i.e., visit schedule, eye mask, equipment, and application body regions), but without joules.

Patients in this placebo arm will have the opportunity to receive the real treatment at the end of the study if they wish.
Experimental: Experimental arm

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
Device: Photobiomodulation sessions
The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group
Time Frame: from the baseline to 12 weeks after the treatment
the proportion of responders to a photobiomodulation intervention on their neuropathic pain at 12 weeks
from the baseline to 12 weeks after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the evolution of neuropathic pain
Time Frame: from the baseline to 6 months after the treatment
description by the scores of the clinician-rated neuropathic pain questionnaire (from 0 to 10, 0 no neuropathic pain, 10 : worst neuropatic pain)
from the baseline to 6 months after the treatment
Description of the evolution of neuropathic pain
Time Frame: from the baseline to 6 months after the treatment
description by the scores of the self-questionnaire Neuropathic Pain Symptom Inventory (from 0 to 100, 0 no neuropathic pain, 100 : worst neuropatic pain)
from the baseline to 6 months after the treatment
Exploration of the evolution of global pain measures
Time Frame: from the baseline to 6 months after the treatment
The global pain will be assessed using the scores of the self-questionnaire Brief Pain Inventory (from 0 to 110, 0 no neuropathic pain, 110 : worst neuropatic pain)
from the baseline to 6 months after the treatment
Exploration of the evolution of global pain measures
Time Frame: from the baseline to 6 months after the treatment
The global pain will be assessed using the scores of the Numeric Scale of pain (from 0 to 10, 0 no pain, 10 worst pain)
from the baseline to 6 months after the treatment
Description of the evolution of the Chemotherapy-induced peripheral neuropathy
Time Frame: from the baseline to 6 months after the treatment
The chemotherapy-induced peripheral neuropathy will be described using the scores of the self-questionnaire FACT/GOG-Ntx-13, and the grade of chemotherapy-induced peripheral neuropathy assessed by the clinician via the Common Terminology Criteria for Adverse Events (ranging from 0 to 5, a high score indicates a strong neuropathy).
from the baseline to 6 months after the treatment
Exploration of the evolution of quality of life
Time Frame: from the baseline to 6 months after the treatment
The quality of life will be explored using the self-questionnaire Functional Assessment of Chronic illness Therapy-Global scores [the global score and its 4 sub-scales scores (physical, social/family, emotional, functional] and the number of falls reported by the patient during the last month (from 0 to 108, 0 bad quality of life, 108 good quality of life)
from the baseline to 6 months after the treatment
Exploration of the evolution of sleep disorders
Time Frame: from the baseline to 6 months after the treatment
Sleep disorders will be explored using the self-assessment Sleep Severity Index (ISI).
from the baseline to 6 months after the treatment
Description of the evolution of neurocognitive executive functioning
Time Frame: from the baseline to 6 months after the treatment
Neurocognitive functioning will be assessed using the clinician-rated scores of the test modified-Delis-Kaplan Executive Function System (m-DKEFS)
from the baseline to 6 months after the treatment
Description of the evolution of neurocognitive executive functioning
Time Frame: from the baseline to 6 months after the treatment
Neurocognitive functioning will be assessed using the scores of the Trail Making Test (TMT A and B)
from the baseline to 6 months after the treatment
Assessment of the photobiomodulation adherence
Time Frame: from the baseline to 4 weeks after the beginning of the treatment
The adherence to the intervention will be assessed by the number of PBM sessions performed by patients
from the baseline to 4 weeks after the beginning of the treatment
Evaluation of the safety of the photobiomodulation
Time Frame: from the baseline to 6 months after the treatment
The safety of PBM will be assessed by the number and the severity of target adverse events recorded during the study period, using the CTCAE scale (v5.0)
from the baseline to 6 months after the treatment
Assessment of emotional distress
Time Frame: from the baseline to 4 weeks after the treatment
Emotional distress will be measured by the score of the Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and at the end of photobiomodulation treatment
from the baseline to 4 weeks after the treatment

Collaborators and Investigators

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Director: Estelle GUERDOUX, PHD, Institut Regional du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 7, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2024605 NEU
  • 2024-A02524-43 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request

IPD Sharing Time Frame

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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