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

Not Applicable

Not yet recruiting

• Conditions: Cancer Survivors; Peripheral Neuropathic Pain

• Registration Number: NCT06834685
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-06
• Study Start: 2025-09
• Primary Completion: 2028-05
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 blood 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Description of the evolution of neuropathic pain	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)
Exploration of the evolution of global pain measures	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)
Description of the evolution of the Chemotherapy-induced peripheral neuropathy	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).
Exploration of the evolution of quality of life	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)
Exploration of the evolution of sleep disorders	from the baseline to 6 months after the treatment	Sleep disorders will be explored using the self-assessment Sleep Severity Index (ISI).
Description of the evolution of neurocognitive executive functioning	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)
Assessment of the photobiomodulation adherence	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
Evaluation of the safety of the photobiomodulation	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)

Trial Locations

Locations (1)

ICM; 🇫🇷 Montpellier, France