Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-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: Surgical Gloves.
- Кому может быть актуально
- Состояния в реестре: Colon Cancer, Oxaliplatin-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
- Бразилия
- 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
GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
Обзор
The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy.
Подробное описание
Gastrointestinal tumors account for one-quarter of the global cancer incidence and one-third of cancer-related deaths. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of oxaliplatin-based treatments. CIPN can lead to an extremely painful and debilitating process, causing significant loss of functional abilities and negatively affecting the quality of life of these patients, as well as activities of daily living (ADLs) such as walking, buttoning clothes, writing, brushing teeth, among others. This condition can even result in a state of vulnerability, with a high risk of falls and other injuries.
Primary Objective and Study Rationale:
Oxaliplatin, widely used to treat patients with colorectal neoplasms, is associated with chemotherapy-induced peripheral neuropathy (CIPN). Given the high prevalence and negative impact of CIPN on quality of life and adherence to cancer treatment, there is a significant gap in identifying effective prevention and management strategies. Although recent evidence suggests that surgical gloves (SG) can mitigate paclitaxel-induced peripheral neuropathy, SGs have not been tested for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). Therefore, the primary objective of this randomized clinical trial is to evaluate whether the use of SGs during treatment can prevent the occurrence of grade 2 or higher OIPN in the hands, as assessed by CTCAE v5.0 and PRO-CTCAE.
Secondary Objective:
To determine the relationship between Body Mass Index and the presence of sarcopenia, with the occurrence of OIPN; To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; To assess symptoms and functional limitations associated with OIPN using the EORTC QLQ-CIPN20 questionnaire.
Вмешательства
- Устройство Surgical Gloves
During each chemotherapy cycle, patients in the experimental group will wear compressive surgical gloves (one size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion.
Первичные конечные точки
- Oxaliplatin-Induced Peripheral Neuropathy [Срок оценки: Baseline, 2 months, 4 months and 6 months]
Вторичные конечные точки (4)
- Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2). [Срок оценки: Baseline, 2 months, 4 months and 6 months]
- Health-related Quality of life questionaries [Срок оценки: Baseline, 2 months, 4 months and 6 months]
- Functional limitations associated with OIPN [Срок оценки: Baseline, 2 months, 4 months and 6 months]
- Patient reported Peripheral Neuropathy [Срок оценки: Baseline, 2 months, 4 months and 6 months]
Критерии участия
Критерии включения
- Patients aged 18 years or older who have provided written informed consent.
- Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV.
- Oxaliplatin-based treatment in the context of localized or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Критерии исключения
- Pre-existing neuropathy.
- Uncontrolled diabetes.
- known glove allergies.
- Prior treatment with paclitaxel, docetaxel or oxaliplatin.
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
- Открытое
- Основная цель
- Профилактика
Центры проведения
Бразилия · 1 центр
- A.C. Camargo Cancer Center — São Paulo
Публикации
- Smith EM. Current methods for the assessment and management of taxane-related neuropathy. Clin J Oncol Nurs. 2013 Feb;17 Suppl:22-34. doi: 10.1188/13.CJON.S1.22-34. PMID 23360700
- Soveri LM, Lamminmaki A, Hanninen UA, Karhunen M, Bono P, Osterlund P. Long-term neuropathy and quality of life in colorectal cancer patients treated with oxaliplatin containing adjuvant chemotherapy. Acta Oncol. 2019 Apr;58(4):398-406. doi: 10.1080/0284186X.2018.1556804. Epub 2019 Jan 14. PMID 30638100
- Tofthagen C. Patient perceptions associated with chemotherapy-induced peripheral neuropathy. Clin J Oncol Nurs. 2010 Jun;14(3):E22-8. doi: 10.1188/10.CJON.E22-E28. PMID 20529785
- Wang S, Zheng R, Li J, Zeng H, Li L, Chen R, Sun K, Han B, Bray F, Wei W, He J. Global, regional, and national lifetime risks of developing and dying from gastrointestinal cancers in 185 countries: a population-based systematic analysis of GLOBOCAN. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):229-237. doi: 10.1016/S2468-1253(23)00366-7. Epub 2024 Jan 4. PMID 38185129
Идентификаторы
NCT: NCT07285356 · 90669425.4.1001.5432