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

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.