Laser therapy to reduce neuropathic pain after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Icm
  Montpellier, France Recruiting
• Centre Azuréen de Cancérologie
  Mougins, Alpes Maritimes, France Not yet recruiting

Study contacts

• Study coordinator: Aurore MOUSSION
• Email: drci-icm105@icm.unicancer.fr
• Phone: 0467613102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.