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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02524-43 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 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 |
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| Control arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation sessions | Device | The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from the baseline to 12 weeks after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from the baseline to 6 months after the treatment |
| Description of the evolution of neuropathic pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurore MOUSSION | Contact | 0467613102 | +33 | drci-icm105@icm.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Estelle GUERDOUX, PHD | INSTITUT REGIONAL DU CANCER DE MONTPELLIER | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICM | Recruiting | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25261162 | Background | Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23. | |
| 35312857 | Background |
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All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
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description by the scores of the self-questionnaire Neuropathic Pain Symptom Inventory (from 0 to 100, 0 no neuropathic pain, 100 : worst neuropatic pain) |
| from the baseline to 6 months after the treatment |
| 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) | from the baseline to 6 months after the treatment |
| 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) | from the baseline to 6 months after the treatment |
| Description of the evolution of the Chemotherapy-induced peripheral neuropathy | The chemotherapy-induced peripheral neuropathy will be described using the scores of the self-questionnaire FACT/GOG-Ntx-13, and the grade of chemotherapy-induced peripheral neuropathy assessed by the clinician via the Common Terminology Criteria for Adverse Events (ranging from 0 to 5, a high score indicates a strong neuropathy). | from the baseline to 6 months after the treatment |
| Exploration of the evolution of quality of life | The quality of life will be explored using the self-questionnaire Functional Assessment of Chronic illness Therapy-Global scores [the global score and its 4 sub-scales scores (physical, social/family, emotional, functional] and the number of falls reported by the patient during the last month (from 0 to 108, 0 bad quality of life, 108 good quality of life) | from the baseline to 6 months after the treatment |
| Exploration of the evolution of sleep disorders | Sleep disorders will be explored using the self-assessment Sleep Severity Index (ISI). | from the baseline to 6 months after the treatment |
| Description of the evolution of neurocognitive executive functioning | Neurocognitive functioning will be assessed using the clinician-rated scores of the test modified-Delis-Kaplan Executive Function System (m-DKEFS) | from the baseline to 6 months after the treatment |
| Description of the evolution of neurocognitive executive functioning | Neurocognitive functioning will be assessed using the scores of the Trail Making Test (TMT A and B) | from the baseline to 6 months after the treatment |
| Assessment of the photobiomodulation adherence | The adherence to the intervention will be assessed by the number of PBM sessions performed by patients | from the baseline to 4 weeks after the beginning of the treatment |
| Evaluation of the safety of the photobiomodulation | The safety of PBM will be assessed by the number and the severity of target adverse events recorded during the study period, using the CTCAE scale (v5.0) | from the baseline to 6 months after the treatment |
| Assessment of emotional distress | Emotional distress will be measured by the score of the Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and at the end of photobiomodulation treatment | from the baseline to 4 weeks after the treatment |
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