Меню
Идёт набор NCT06763575

Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy

Без фазы С лечением Paclitaxel-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 Glove-Compression Therapy, non-compressive plastic gloves.
Кому может быть актуально
Состояния в реестре: Paclitaxel-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
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial

Обзор

The aim of this randomized controlled trial (RCT) is to compare the incidence of paclitaxel-induced grade 2 or higher sensory peripheral neuropathy, evaluated using the CTCAE version 5.0, between patients receiving surgical glove-compression therapy (SGCT) and those in the control group. The main question is whether SGCT is effective in preventing paclitaxel-induced sensory peripheral neuropathy. * Intervention group: receive SGCT. * Control group: receive non-compressive plastic gloves.

Подробное описание

1. The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy. 2. The primary objective is to determine the incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy, assessed using the CTCAE version 5.0. Secondary objectives include evaluating the incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE version 5.0, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) score, the incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy as measured by the Patient Neurotoxicity Questionnaire (PNQ), and the outcomes from the monofilament test. 3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients. 4. Randomization into two groups. The intervention arm will receive SGCT, while the control arm will receive non-compressive plastic gloves. The duration of treatment is 9 weeks. 5. Enrollment and data monitoring are assessed by staff at the Oncology Unit, Rajavithi Hospital, and the data will be recorded in a computer-based information system. 6. Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment. 7. Data analyzed by descriptive and inferential statistics.

Вмешательства

  • Устройство Surgical Glove-Compression Therapy
    In the intervention group, patients wore double-layered surgical gloves, one size smaller than measured, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy.
  • Устройство non-compressive plastic gloves
    In the control group, patients wore non-compressive plastic gloves, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy.

Первичные конечные точки

  • Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0. [Срок оценки: 9 weeks]
Вторичные конечные точки (4)
  • Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0 [Срок оценки: 9 weeks]
  • FACT/GOG-NTX scores [Срок оценки: 9 weeks]
  • Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ [Срок оценки: 9 weeks]
  • Monofilament test results [Срок оценки: 9 weeks]

Критерии участия

Критерии включения

  • Signed Informed Consent Form
  • Age 18 years or older at the time of signing Informed Consent Form
  • Patients with any pathological diagnosis of solid tumor, such as breast cancer or lung cancer
  • Patients scheduled to be receiving intravenous paclitaxel or paclitaxel-based regimen every 3 weeks

Критерии исключения

  • Patients whose received chemotherapeutic agents that could cause neuropathy, e.g. taxane-based or platinum-based chemotherapy and anti-microtubule
  • History of neuropathy
  • History of carpal tunnel syndrome
  • History of allergic reactions to latex or gloves
  • Patients receiving treatments that may treat neuropathy, e.g. amitriptyline, gabapentin, Acetyl L-Carnitine and Ganglioside-monosialic acid, acupuncture, cryotherapy or exercise therapy
  • History of Raynaud phenomenon
  • History of wounds or large scars on hands
  • Pregnancy or breastfeeding
  • History of poorly controlled diabetes; HbA1c>6.5

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
Четверное слепое
Основная цель
Профилактика

Центры проведения

Таиланд · 1 центр
  • Rajavithi Hospital, Medical Oncology Unit — Bangkok

Идентификаторы

NCT: NCT06763575 · 67171

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗