Laser therapy to reduce neuropathic pain after chemotherapy

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

This trial tests whether repeated low-level laser (photobiomodulation) sessions can reduce neuropathic pain in adult cancer survivors who developed peripheral neuropathy after chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Montpellier)
• Trial ID: NCT06834685 on ClinicalTrials.gov

What this trial studies

This interventional study delivers repeated photobiomodulation (low-level laser) sessions to adult cancer survivors with persistent chemotherapy-induced peripheral neuropathy and neuropathic pain. Eligible patients are adults treated at the Institut du Cancer de Montpellier with neuropathic pain lasting at least three months after adjuvant or neoadjuvant chemotherapy and a clinician-rated DN4 score of 4 or higher. The protocol requires in-person treatment visits in Montpellier, pregnancy testing and contraception requirements for women of childbearing potential, and collection of pain and quality-of-life measures over the treatment period. There is no phase listed; outcomes will focus on symptom change and tolerability of the laser sessions.

Who should consider this trial

Good fit: Ideal candidates are adults treated at the Montpellier center who have persistent neuropathic pain for at least three months after chemotherapy, a DN4 score ≥4, can consent, are fluent in French, and are covered by the French social protection system.

Not a fit: Patients with non-neuropathic pain, recent chemotherapy-related symptoms under three months, those who do not meet the DN4 pain threshold, pregnant women, or those unable to attend in-person sessions in Montpellier are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could provide a non-drug option to lower neuropathic pain and improve function and quality of life for cancer survivors with CIPN.

How similar studies have performed: Small trials of low-level laser therapy for neuropathic pain and CIPN have shown mixed but sometimes promising symptom reductions, though evidence remains limited and not definitive.

Eligibility criteria

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.

Where this trial is running

Montpellier

• Icm — Montpellier, France (Recruiting)

Study contacts

• Study coordinator: Aurore MOUSSION

Conditions Cancer Survivors; Peripheral Neuropathic Pain