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

NCT07681921 | Not Yet Recruiting

• 1 other identifier: IJB-EARLYNEUROLASER-2026
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Keywords

photobiomodulation and peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• severity of CIPN measured by modified Total Neurpathy Score m-TNS

  Include several simple neurological tests

  At baseline (week 0) and at week 3 and week 6

Secondary Outcomes (3)

• Pain & satisfaction by Numeric Rating Scale (0-10)

  At baseline (Week0), and Week 3 and Week 6

• Mobility by 6min walking test

  At baseline (Week0), and Week 3 and Week 6

• Quality of life by FACT-GOG-NTX questionnair

  At baseline (Week0), and Week 3 and Week 6

Study Arms (2)

PBM group

EXPERIMENTAL

Patient will recieve photobiomodulation of 20J/cm2 twice a week.

Device: Photobiomodulation

Sham-PBM group

SHAM COMPARATOR

Patient will recieve a simulated treatment by photobiomodulation twice a week.

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Patients will receive 20 Joule/cm2

Also known as: Low Level Laser

PBM group; Sham-PBM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, Brabant, 1070, Belgium

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)