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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Photobiomodulation sessions
  The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm

Первичные конечные точки

• Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group [Срок оценки: from the baseline to 12 weeks after the treatment]

Вторичные конечные точки (12)

• Description of the evolution of neuropathic pain [Срок оценки: from the baseline to 6 months after the treatment]
• Description of the evolution of neuropathic pain [Срок оценки: from the baseline to 6 months after the treatment]
• Exploration of the evolution of global pain measures [Срок оценки: from the baseline to 6 months after the treatment]
• Exploration of the evolution of global pain measures [Срок оценки: from the baseline to 6 months after the treatment]
• Description of the evolution of the Chemotherapy-induced peripheral neuropathy [Срок оценки: from the baseline to 6 months after the treatment]
• Exploration of the evolution of quality of life [Срок оценки: from the baseline to 6 months after the treatment]
• Exploration of the evolution of sleep disorders [Срок оценки: from the baseline to 6 months after the treatment]
• Description of the evolution of neurocognitive executive functioning [Срок оценки: from the baseline to 6 months after the treatment]
• Description of the evolution of neurocognitive executive functioning [Срок оценки: from the baseline to 6 months after the treatment]
• Assessment of the photobiomodulation adherence [Срок оценки: from the baseline to 4 weeks after the beginning of the treatment]
• Evaluation of the safety of the photobiomodulation [Срок оценки: from the baseline to 6 months after the treatment]
• Assessment of emotional distress [Срок оценки: from the baseline to 4 weeks, 8 weeks and 12 weeks after the treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• Centre Azuréen de Cancérologie — Mougins
• ICM — Montpellier

Публикации

• 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. PMID 25261162
• Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21. PMID 35312857
• Teng C, Egger S, Blinman PL, Vardy JL. Evaluating laser photobiomodulation for chemotherapy-induced peripheral neuropathy: a randomised phase II trial. Support Care Cancer. 2022 Dec 17;31(1):52. doi: 10.1007/s00520-022-07463-y. PMID 36526802
• Zadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis i PMID 31286228
• Escritt K, Mann M, Nelson A, Harrop E. Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences. Trials. 2022 May 16;23(1):409. doi: 10.1186/s13063-022-06306-9. PMID 35578308
• D'Souza RS, Alvarez GAM, Dombovy-Johnson M, Eller J, Abd-Elsayed A. Evidence-Based Treatment of Pain in Chemotherapy-Induced Peripheral Neuropathy. Curr Pain Headache Rep. 2023 May;27(5):99-116. doi: 10.1007/s11916-023-01107-4. Epub 2023 Apr 14. PMID 37058254
• Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023 Nov;25(11):1227-1235. doi: 10.1007/s11912-023-01449-7. Epub 2023 Sep 13. PMID 37702983
• Kerckhove N, Collin A, Conde S, Chaleteix C, Pezet D, Balayssac D, Guastella V. [Chemotherapy-induced peripheral neuropathy: Symptomatology and epidemiology]. Bull Cancer. 2018 Nov;105(11):1020-1032. doi: 10.1016/j.bulcan.2018.07.009. Epub 2018 Sep 20. French. PMID 30244980

Идентификаторы

NCT: NCT06834685 · PROICM 2024605 NEU · 2024-A02524-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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