Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
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: Photobiomodulation therapy (PBMT).
- Кому может быть актуально
- Состояния в реестре: Hand-foot Syndrome, Hand-foot Skin Reaction. 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 Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
Обзор
Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL). Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.
Подробное описание
The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.
Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).
Secondary objective 1 : HFS/HFSR-related symptoms
A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT
Secondary Objective 2: Quality of life
A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT
Secondary Objective 3: Patient satisfaction
A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT
Secondary Objective 4: PBM safety
A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.
Вмешательства
- Устройство Photobiomodulation therapy (PBMT)
Patients will receive PBM on the sole of their feet and palms of their hands
Первичные конечные точки
- Skin reaction evaluation - CTCAE [Срок оценки: Baseline]
- Skin reaction evaluation - CTCAE [Срок оценки: Session 3 of PBMT]
- Skin reaction evaluation - CTCAE [Срок оценки: Session 6 of PBMT]
- Skin reaction evaluation - CTCAE [Срок оценки: Final PBM session (session 9)]
- Skin reaction evaluation - CTCAE [Срок оценки: 2 weeks post-PBMT]
- Skin reaction evaluation - WHO [Срок оценки: Baseline]
- Skin reaction evaluation - WHO [Срок оценки: Session 3 of PBMT]
- Skin reaction evaluation - WHO [Срок оценки: Session 6 of PBMT]
- Skin reaction evaluation - WHO [Срок оценки: Final PBM session (session 9)]
- Skin reaction evaluation - WHO [Срок оценки: 2 weeks post-PBMT]
Вторичные конечные точки (12)
- Patient subjective evaluation of skin reactions [Срок оценки: Baseline]
- Patient subjective evaluation of skin reactions [Срок оценки: Session 3 of PBMT]
- Patient subjective evaluation of skin reactions [Срок оценки: Session 6 of PBMT]
- Patient subjective evaluation of skin reactions [Срок оценки: Final PBM session (Session 9)]
- Patient subjective evaluation of skin reactions [Срок оценки: 2 weeks post-PBMT]
- Quality of life - DLQI [Срок оценки: Baseline]
- Quality of life - DLQI [Срок оценки: Session 3 of PBMT]
- Quality of life - DLQI [Срок оценки: Session 6 of PBMT]
- Quality of life - DLQI [Срок оценки: Final PBM session (session 9)]
- Quality of life - DLQI [Срок оценки: 2 weeks post-PBMT]
- Quality of life - Skindex-29 [Срок оценки: Baseline]
- Quality of life - Skindex-29 [Срок оценки: Session 3 of PBMT]
Критерии участия
Критерии включения
- Diagnosed with cancer of different aetiologies
- Undergoing chemotherapy or targeted therapy (TKIs)
- Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
Критерии исключения
- Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot)
- Known allergy to polyurethane
- Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Бельгия · 2 центра
- Hasselt University — Hasselt
- Jessa Ziekenhuis VZW — Hasselt
Идентификаторы
NCT: NCT04979078 · 2021/071