Идёт набор NCT04135586

Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer

Без фазы С лечением Physical Exercise

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: Exercise training, Control.
Кому может быть актуально: Состояния в реестре: Physical Exercise. Базовые параметры: 25 лет — 75 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: Испания
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 a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer

Обзор

To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).

Подробное описание

Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.

Principal aim:

Secondary aims:

To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.

Вмешательства

Другое Exercise training
Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale.
Другое Control
Yoga + educational program

Первичные конечные точки

Cardiorespiratory fitness [Срок оценки: Change from baseline to end of intervention (i.e., after 24 weeks)]
muscle dynamic strength [Срок оценки: Change from baseline to end of intervention (i.e., after 24 weeks)]
handgrip strength [Срок оценки: Change from baseline to end of intervention (i.e., after 24 weeks)]

Вторичные конечные точки (3)

Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23]) [Срок оценки: Change from baseline to end of intervention (i.e., after 24 weeks)]
Body composition (fat mass) [Срок оценки: Change from baseline to end of intervention (i.e., after 24 weeks)]
Body composition (lean body mass) [Срок оценки: Change from baseline to end of intervention (i.e., after 24 weeks)]

Критерии участия

Критерии включения

Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size > or equal to 15 mm