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.
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;
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);
Parallel
Photobiomodulation sessions
DeviceThe treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm
Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group
the proportion of responders to a photobiomodulation intervention on their neuropathic pain at 12 weeks
Description of the evolution of neuropathic pain
description by the scores of the clinician-rated neuropathic pain questionnaire (from 0 to 10, 0 no neuropathic pain, 10 : worst neuropatic pain)
Description of the evolution of neuropathic pain
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
The global pain will be assessed using the scores of the self-questionnaire Brief Pain Inventory (from 0 to 110, 0 no neuropathic pain, 110 : worst neuropatic pain)
Exploration of the evolution of global pain measures
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)
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