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ClinicalTrials.gov ID

NCT06834685

Lead Sponsor

Institut du Cancer de Montpellier - Val d'AurelleOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

70Estimated

Last Update Posted

Jul 28, 2026Actual

Start Date

Oct 7, 2025Actual

Primary Completion Date

May 2028Estimated

Completion Date

Dec 2028Estimated

Official Title

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

Brief Summary

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.

• Cancer Survivors
• Peripheral Neuropathic Pain

• Photobiomodulation sessions

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Male or female aged 18 years minimum;
• Patient with cancer, whatever the location;
• 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 investigator center;
• 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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Institut du Cancer de Montpellier - Val d'AurelleOTHER

estelle.guerdoux@icm.unicancer.fr0467612468 ext. +33