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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
ICM
RECRUITING
Montpellier
Contact Information
Primary
Aurore MOUSSION
drci-icm105@icm.unicancer.fr
0467613102
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2028-12
Participants
Target number of participants: 70
Treatments
Experimental: Experimental arm
Photobiomodulation sessions (2 per week for 4 weeks, 8 sessions in total) will be delivered by certified laser safety clinicians (i.e., algologists, pain nurses or neuropsychologists).~The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm. The light will be applied to all hands and/or feet for 13 minutes. The order of transfer between feet and hands will be counterbalanced so that, half of the sessions will have started with feet, and the other half will have started with hands. The dose will be specified at each session.~Patients will be treated in a sitting position (to treat the hands) or a semi-seated position (for feet). They will wear opaque glasses to ensure the safety of the laser and the blind condition of treatment
No_intervention: Control arm
In the sham therapy, patients will have the same procedure as the laser intervention (i.e., visit schedule, eye mask, equipment, and application body regions), but without joules.~Patients in this placebo arm will have the opportunity to receive the real treatment at the end of the study if they wish.
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov