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Идёт набор NCT07472803

Longitudinal Body Composition Assessment in Breast Cancer Patients

— Наблюдательное Breast Neoplasms Body Composition Sarcopenia Fat Redistribution

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms, Body Composition, Sarcopenia, Fat Redistribution. 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
Тайвань
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

Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer

Обзор

This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period. The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.

Первичные конечные точки

  • Change in Skeletal Muscle Mass Index (SMI) [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
Вторичные конечные точки (10)
  • Functional Battery: Change from Baseline in Handgrip Strength [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Functional Battery: Change from Baseline in 4-Meter Gait Speed [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Functional Battery: Change from Baseline in 30-Second Chair Stand Test [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Body Composition: Change from Baseline in Body Fat Mass [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Change from Baseline in Overall Edema Index [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Change from Baseline in Extracellular Water (ECW) [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
  • Change from Baseline in Intracellular Water (ICW) [Срок оценки: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]

Критерии участия

Критерии включения

  • >18 years of age
  • Diagnosed with stage I-III non-metastatic breast cancer within 12 months of diagnosis
  • Scheduled for surgery, chemotherapy, with or without radiotherapy or targeted therapy.

Критерии исключения

  • Women diagnosed with metastatic (stage IV) breast cancer
  • Women planning to move away from the area or be away for more than 6 months during the study period
  • Women planning to become pregnant during the study period
  • Implantable devices (e.g., pacemaker, nerve stimulator) or surgical implants (e.g., total hip or knee replacements)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 1 центр
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — New Taipei City

Идентификаторы

NCT: NCT07472803 · 13-IRB110-OBS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗