Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy).
- Кому может быть актуально
- Состояния в реестре: Chemotherapy-induced Peripheral Neuropathy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial
Обзор
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.
Подробное описание
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Our research group showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data). PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. The aim of this project is to evaluate the effectiveness of PBM in the management of CIPN in general.
Вмешательства
- Устройство Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated.
Первичные конечные точки
- Modified total neuropathy score (mTNS) [Срок оценки: Baseline]
- Modified total neuropathy score (mTNS) [Срок оценки: End of PBM (six weeks post-baseline)]
- Modified total neuropathy score (mTNS) [Срок оценки: Three weeks post-PBM]
- Pain score [Срок оценки: Baseline]
- Pain score [Срок оценки: End of PBM (six weeks post-baseline)]
- Pain score [Срок оценки: Three weeks post-PBM]
- Mobility score [Срок оценки: Baseline]
- Mobility score [Срок оценки: End of PBM (six weeks post-baseline)]
- Mobility score [Срок оценки: Three weeks post-PBM]
Вторичные конечные точки (6)
- Quality of life score [Срок оценки: Baseline]
- Quality of life score [Срок оценки: End of PBM (six weeks post-baseline)]
- Quality of life score [Срок оценки: Three weeks post-PBM]
- Satisfaction score [Срок оценки: Baseline]
- Satisfaction score [Срок оценки: End of PBM (six weeks post-baseline)]
- satisfaction score [Срок оценки: Three weeks post-PBM]
Критерии участия
Критерии включения
- Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
- Diagnosed with CIPN
- Age 18 years or above
- Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
- Dutch-speaking
- Signed informed consent
Критерии исключения
- Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
- Severe or unstable cardio- respiratory or musculoskeletal disease
- Interruption of more than two consecutive laser treatments
- Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)
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
- Лечение
Центры проведения
Бельгия · 1 центр
- Jessa Hospital — Hasselt
Идентификаторы
NCT: NCT05763706 · 2023/007