Меню
Идёт набор NCT07064798

Cryocompression for CIPN

Без фазы С лечением Chemotherapy-induced Peripheral Neuropathy Taxane-Induced Peripheral Neuropathy CIPN - 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: Paxman Limb Cryocompression System.
Кому может быть актуально
Состояния в реестре: Chemotherapy-induced Peripheral Neuropathy, Taxane-Induced Peripheral Neuropathy, CIPN - 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
США
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

Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy

Обзор

This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. The name of the device used in this research study is: -Paxman Limb Cryocompression System (PLCS)

Подробное описание

This randomized controlled trial aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. There is evidence that cooling therapy may be effective for preventing peripheral neuropathy caused by taxane-based chemotherapy.

The U.S. Food and Drug Administration (FDA) has not approved the PAXMAN Limb Cryocompression System as a treatment to reduce peripheral neuropathy.

Participants will be randomized into 1 of 2 groups: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy versus Arm B: Standard of Care Taxane-Based Chemotherapy. Participants will be randomized in a 2:1 manner, meaning a participant is 2 times the chance (approximately 67%) of being in Arm A than in Arm B (approximately 33%). Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and questionnaires.

It is expected that about 50 people will take part in this research study.

Paxman Coolers, Inc. is providing the Paxman Limb Cryocompression Systems for this study.

Вмешательства

  • Устройство Paxman Limb Cryocompression System
    An investigational device designed to provide controlled cooling and compression to participant limbs during chemotherapy administration. The device is comprised of a control unit, connecting hose, and two limb wraps. The customizable limb wraps delivers continuous-flow cooling-and-compression to participant extremities

Первичные конечные точки

  • Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment [Срок оценки: Assessed 1-4 weeks after the final taxane infusion (end of treatment).]
  • Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy [Срок оценки: Up to 12 weeks]
  • Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression [Срок оценки: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks]

Критерии участия

Критерии включения

  • Adults > 18 years of age
  • Gynecologic or breast malignancy
  • Starting 1st cycle of treatment with chemotherapy regimens:
  • Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (Breast Oncology)
  • Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)
  • Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)
  • Able to complete questionnaires in English or Spanish

Критерии исключения

  • Previous exposure to neurotoxic chemotherapy
  • Pre-existing neuropathy
  • History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease
  • Undergoing desensitization
  • Lymphedema in the limb where the device would be applied
  • Open skin wounds or ulcers of the limbs where the device would be applied

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
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT07064798 · 25-144

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗