Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer
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: Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA.
- Кому может быть актуально
- Состояния в реестре: CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer. 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
- Дания
- 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
Effects of Cryotherapy on Objective and Subjective Symptoms of Taxane-Induced Neuropathy in Patients With Early Breast Cancer: A National, Multicenter, Prospective, Randomized, Controlled Trial
Обзор
Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.
Подробное описание
BACKGROUND: Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.
OBJECTIVES:
Primary objective: To assess the efficacy of cryotherapy to prevent paclitaxel chemotherapy induced peripheral neuropathy (CIPN) Secondary objective: To search for risk factors for CIPN. METHOD Study Design: A national, multicenter, interventional, randomized, non-blinded clinical trial evaluating the preventive effects of cryotherapy for CIPN.
Eligibility: Key inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 doses, PS 0-1.
Sample size: 300 Randomization: Participants will be randomized 1:1 to A: use of Elasto-Gel™ frozen glove and sock on their hands and feet during paclitaxel treatment or B: standard treatment. Randomization will be performed in REDCap using the Electronic Case Report Forms (eCRFs).
Cryotherapy Intervention: Patients in the experimental arm will wear glycerine-containing Elasto-Gel™ gloves and socks (Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA) over a disposable glove and sock liner secured by Velcro at the wrist and ankle on their hands and feet from 15 minutes before paclitaxel administration to 15 minutes after the infusion is complete (90 minutes in total).
Primary outcomes: Incidence of peripheral neuropathy; CIPN is assessed using the Total Neuropathy Score reduced version (TNSr) 21 days after last completed cycle of paclitaxel and compared to baseline.
Key secondary outcomes: Objective symptoms - Quantitative sensory testing (QST).
Subjective symptoms - Patient Reported Outcome: (EORTC Quality of Life Questionnaire (QLQ)-C30 and EORTC (QLQ)-CIPN20), pain and tolerability etc.
Вмешательства
- Устройство Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA
Patients in the experimental arm will wear glycerine-containing Elasto-Gel™ gloves and socks (Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA) over a disposable glove and sock liner secured by Velcro at the wrist and ankle on their hands and feet from 15 minutes before paclitaxel administration to 15 minutes after the infusion is complete (90 minutes in total).
Первичные конечные точки
- Incidence of peripheral neuropathy [Срок оценки: CIPN is assessed 21 days after last completed cycle of paclitaxel and compared to baseline.]
Критерии участия
Критерии включения
Key inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 or 12 doses, PS 0-1
Критерии исключения
Peripheral sensory/motor neuropathy, neuralgia or edema of the limb graded >=2 (CTCAE ver 5.0), Patient with Raynaud's symptoms; peripheral arterial ischemia; or any other reasons based on the primary physician's judgment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Дания · 1 центр
- Maria E Lendorf — Copenhagen
Идентификаторы
NCT: NCT05928429 · CryoPac