Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy (ENL)

July 1, 2026 updated by: Jules Bordet Institute
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with " de novo " early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy-induced peripheral neuropathy (PN) is a common side-effect of many anti-neoplastic agents; its prevalence is estimated to 20-50% but varies considerably according to many factors and might actually be underreported. PN is increasingly reported as a complication of cancer immunotherapy and various targeted therapies currently used for the treatment of cancer.

PN typically causes disabling, sensitive (paresthesia, dysesthesia, allodynia, loss of sensation), but can also cause motor dysfunction (muscle weakness, fatigue) and autonomic dysfunction (digestive disorders, orthostatic hypotension); once established, regression of symptoms is slow. The pathobiology of chemotherapy-induced PN is mainly unknown despite the documented involvement of neuroinflammatory, mitochondrial, and vascular mechanisms.

PN often compromises quality of life and is a frequent reason for dose reduction, treatment delay, or premature discontinuation of anticancer therapy.

So far, no standard therapy has been recommended, with the possible exception of duloxetine, which has been associated with a modest symptom improvement in cisplatin-treated patients.

In this context, innovative, non-pharmacological, and well-tolerated strategies are needed. Photobiomodulation (PBM), also known as low-level laser therapy (LLLT), uses specific wavelengths (red or near-infrared) to modulate cellular activity, promote nerve regeneration, reduce inflammation, and regulate pain. Already included in international recommendations for the management of oral mucositis induced by chemotherapy or radiotherapy, PBM is emerging as a potentially effective alternative for other cancer-related toxicities.

A beneficial effect of PBM on diabetic PN and oxaliplatin-induced PN has been reported.

Argenta et al. published a small randomized sham-controlled trial of PBM on chemotherapy-induced PN that indicated a significant reduction in neuropathy symptoms. They found a significant benefit already after 4 weeks of therapy and patients who crossed over from sham laser experienced similar benefits. In a pilot trial, Lodewijckx et al. found a considerable decrease in symptoms of chemotherapy-induced PN with PBM. The same group reported " promising " results with PBM for the prevention of chemotherapy-induced PN in breast cancer patients.

Therefore, the investigator plan to evaluate the role of PBM administered to patients with " de novo " early signs of PN that are supposed to be related to ongoing neurotoxic anti-cancer therapy (Bortezomib, Cisplatin, Docetaxel, Enfortumag, Halaven, Oxaliplatin, Paclitaxel, Vinblastine, Vincritsine, Vinorelbine).

The project is therefore part of a proactive approach to supportive care aimed at reducing the early symptoms of PN, improving patients' quality of life, and avoiding the interruption or reduction of cancer therapy doses, using a simple, non-invasive device that has the potential for widespread application.

Study Type

Interventional

Enrollment (Estimated)

98

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 Locations

  • Belgium
    • Brabant
      • Brussels, Brabant, Belgium, 1070
        • Jules Bordet Institute

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:

  • All the patients admitted for medical oncological therapy to the day care facility (Hôpital de Jour) are eligible for the protocol.
  • Age 18 years or above
  • Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
  • Be able to understand the ICF and study-related questionnaires
  • Signed informed consent

Exclusion Criteria:

  • severe or unstable cardio-respiratory or musculoskeletal disease
  • Peripheral neuropathy previous to chemotherapy
  • Receiving potentially neurotoxic therapies other than given for cancer treatment
  • Interruption of more than two consecutive laser treatments

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PBM group
Patient will recieve photobiomodulation of 20J/cm2 twice a week.
Device: Photobiomodulation
Patients will receive 20 Joule/cm2
Other Names:
  • Low Level Laser
Sham Comparator: Sham-PBM group
Patient will recieve a simulated treatment by photobiomodulation twice a week.
Device: Photobiomodulation
Patients will receive 20 Joule/cm2
Other Names:
  • Low Level Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of CIPN measured by modified Total Neurpathy Score m-TNS
Time Frame: At baseline (week 0) and at week 3 and week 6
Include several simple neurological tests
At baseline (week 0) and at week 3 and week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain & satisfaction by Numeric Rating Scale (0-10)
Time Frame: At baseline (Week0), and Week 3 and Week 6
Pain & satisfaction by Numeric Rating Scale (0-10)
At baseline (Week0), and Week 3 and Week 6
Mobility by 6min walking test
Time Frame: At baseline (Week0), and Week 3 and Week 6
Mobility by 6min walking test and
At baseline (Week0), and Week 3 and Week 6
Quality of life by FACT-GOG-NTX questionnair
Time Frame: At baseline (Week0), and Week 3 and Week 6
Quality of life by FACT-GOG-NTX questionnaire
At baseline (Week0), and Week 3 and Week 6

Collaborators and Investigators

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

Sponsor

Jules Bordet Institute

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJB-EARLYNEUROLASER-2026

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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