Меню
Идёт набор NCT06455904

Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study

Без фазы С лечением 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: Training sessions.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
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 →

Обзор

The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.

Подробное описание

There will be two groups of patients after drawing lots using a process called randomization. The probability is one in two of being in the group participating in the training program, the other group following the standard treatment.

Вмешательства

  • Процедура Training sessions
    The training program will be performed during 15 weeks, with one session per week.

Первичные конечные точки

  • Overall exercise capacity [Срок оценки: At week 18 (the end of chemotherapy treatment)]
Вторичные конечные точки (12)
  • Physiological variables associated with exercise capacity - cardiorespiratory capacity [Срок оценки: At weeks 8.]
  • Physiological variables associated with exercise capacity - cardiorespiratory capacity [Срок оценки: At week 18 (the end of chemotherapy treatment)]
  • Physiological variables associated with exercise capacity - muscle function [Срок оценки: At weeks 8.]
  • Physiological variables associated with exercise capacity - muscle function [Срок оценки: At week 18 (the end of chemotherapy treatment)]
  • Physiological variables associated with exercise capacity - body composition [Срок оценки: At weeks 8.]
  • Physiological variables associated with exercise capacity - body composition [Срок оценки: At week 18 (the end of chemotherapy treatment)]
  • Physiological variables associated with exercise capacity - muscle architecture [Срок оценки: At weeks 8.]
  • Physiological variables associated with exercise capacity - muscle architecture [Срок оценки: At weeks 8.]
  • Physiological variables associated with exercise capacity - muscle architecture [Срок оценки: At weeks 8.]
  • Physiological variables associated with exercise capacity - muscle architecture [Срок оценки: At week 18 (the end of chemotherapy treatment)]
  • Physiological variables associated with exercise capacity - muscle architecture [Срок оценки: At week 18 (the end of chemotherapy treatment)]
  • Physiological variables associated with exercise capacity - muscle architecture [Срок оценки: At week 18 (the end of chemotherapy treatment)]

Критерии участия

Критерии включения

  • Woman ≥ 18 years old
  • Stage I to III breast cancer
  • Patient currently planning (neo)adjuvant treatment combining anthracycline-cyclophosphamide and weekly paclitaxel (± trastuzumab)
  • Affiliation to a social security system
  • Able to speak, read and understand French

Критерии исключения

  • No prior chemotherapy treatment
  • Any known cardiac or vascular pathology
  • Contraindications to physical fitness assessment
  • Protected adult
  • Psychiatric, musculoskeletal or neurological problems
  • Pregnant or breastfeeding woman (NB: this population is already subject to a contraindication to (neo)adjuvant treatment. For women of childbearing age, a betaHCG dosage is already carried out systematically before the start of chemotherapy and information on the need for contraception throughout the chemotherapy period is provided before the start of treatment. As part of this study, only the presence of this test with a negative result at the start of chemotherapy will be checked. inclusion, if available).

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

Франция · 2 центра
  • Hôpitaux civils de Colmar — Colmar
  • Institut de cancérologie Strasbourg Europe — Strasbourg

Идентификаторы

NCT: NCT06455904 · 2023-005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗