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

Launched by INSTITUT DU CANCER DE MONTPELLIER - VAL D'AURELLE · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of light therapy called photobiomodulation (PBM) to help relieve neuropathic pain caused by chemotherapy in cancer survivors. Neuropathic pain can cause uncomfortable sensations like tingling, numbness, and pain, which can significantly affect a person’s quality of life. The goal of the study is to see if PBM can safely improve this type of pain in patients who have been experiencing it for at least three months after their chemotherapy treatment.

To be eligible for this study, participants must be at least 18 years old, have been treated for cancer with chemotherapy at the Montpellier Cancer Institute, and have significant neuropathic pain. They also need to be able to attend the clinic twice a week for the treatment sessions. Participants will receive the PBM therapy, which involves using laser light to help reduce pain and inflammation. Throughout the study, they will be monitored for any changes in their pain levels and overall well-being. It's important to note that this trial is not yet recruiting participants, so there will be more information available when it officially starts.

Gender

ALL

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 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