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Идёт набор NCT07439458

Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity

Без фазы С лечением Acute Exercise Breast Cancer Cell Lines Breast Cancer Survivors Healthy Women

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: High intensity continuous exercise, Moderate intensity continuous exercise.
Кому может быть актуально
Состояния в реестре: Acute Exercise, Breast Cancer Cell Lines, Breast Cancer Survivors, Healthy Women. Базовые параметры: от 35 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
Латвия
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

Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity (TCReX) No: RSU/LSPA-PA-2024/1-0004 is Financed by the Investment of the European Union Recovery and Resilience Facility and the State Budget Within the Project "RSU Internal and RSU With LASE External Consolidation" No. 5.2.1.1.i.0/2/24/I/CFLA/005.

Обзор

Cancer has emerged as a prominent cause of mortality in the 21st century, with breast cancer (BC) being the most diagnosed malignancy. Multidisciplinary cancer management has improved survival chances, but side effects and long-term consequences of treatments have significant implications for cancer survivors' health-related quality of life. Exercise is increasingly considered and used in cancer treatment and follow-up. However, studies demonstrating the biological mechanisms underlying the anticarcinogenic effects (ACE) of exercise are insufficient to justify the most appropriate physical activity for different clinical scenarios. Achieving scientific excellence in understanding the ACE of exercise in cancer management is critical to optimize treatment and enhance patients' quality of life.

Вмешательства

  • Другое High intensity continuous exercise
    30 minutes of continuous exercise at 75% of VO2max, additionally 15 minutes of warm-up to reach specific workload.
  • Другое Moderate intensity continuous exercise
    30 minutes of continuous exercise at 45% of VO2max, additionally 15 minutes of warm-up to reach specific workload.

Первичные конечные точки

  • Inhibition of Breast Cancer Cell Proliferation [Срок оценки: 24 hours following cell exposure to serum collected at baseline (5 minutes pre-exercise) and immediately post-exercise (final minute of exercise).]
  • Changes in Serum Myokine Concentrations [Срок оценки: Blood samples were collected 5 minutes pre-exercise (baseline), 15, 30, and 45 minutes (final minute of exercise) at Day 8 (Visit 2) and Day 15 (Visit 3).]
Вторичные конечные точки (1)
  • Correlation Between Body Composition and Myokine Response [Срок оценки: Day 1 (Visit 1): Baseline measurements (measured once during the initial screening). All measures were performed in the morning, from 8 a.m. to 12 p.m., after overnight fasting.]

Критерии участия

Inclusion Criteria (intervention group):

  • Reproductive age (premenopausal);
  • Diagnosis of Stage II-III Triple-Negative Breast Cancer (TNBC) (negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2));
  • Timeframe of 3 to 9 months after completion of surgery, adjuvant chemotherapy, radiation therapy, and/or immunotherapy;
  • Physician-certified (cardiologist) physical fitness for exercise testing, supported by echocardiography (ECHO).

Inclusion Criteria (control group):

  • Reproductive age (premenopausal);
  • No current or prior diagnosis of any type of cancer;
  • Matched by age, body constitution, and physical fitness to the breast cancer participant group.

Критерии исключения

  • Pregnancy;
  • Autoimmune diseases (e.g., thyroiditis, inflammatory bowel disease, atopic dermatitis, etc.);
  • Endocrine disorders (e.g., metabolic syndrome, diabetes);
  • Cardiovascular diseases;
  • Diagnosis of any other type of oncological disease;
  • Any condition for which physical activity is contraindicated (e.g., asthma, COPD, spinal disc herniation, severe iron deficiency anemia).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Латвия · 1 центр
  • Laboratory of Sports and Nutrition Research — Riga

Идентификаторы

NCT: NCT07439458 · 2-PĒK-4/604/2025 · RSU/LSPA-PA-2024/1-0004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗