Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer

Официальное название

NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer

Обзор

In this study, the investigators hypothesize that a high dose of post-workout protein nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.

Вмешательства

• Пищевая добавка Whey protein (20 grams)
  20 grams of whey protein
• Пищевая добавка Whey protein (60 grams)
  60 grams of whey protein.

Первичные конечные точки

• Changes in muscle mass and fat mass (pounds) at completion of chemotherapy [Срок оценки: Baseline and at program completion (within 4 weeks of exercise completion).]

Вторичные конечные точки (10)

• Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST) [Срок оценки: Chemotherapy response assessment is at program completion (within 4 weeks of exercise completion)]
• Changes in EuroQol-5 Dimensions (EQ-5D) at completion of chemotherapy assessment [Срок оценки: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).]
• Changes in Patient Health Questionnaire-9 (PHQ9) depression score at completion of chemotherapy assessment [Срок оценки: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).]
• Changes in General Anxiety Disorder-7 (GAD7) anxiety score at completion of chemotherapy assessment [Срок оценки: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).]
• Changes in activity levels via Godin Leisure-Time Exercise Questionnaire [Срок оценки: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).]
• Changes in resting metabolic rate at completion of chemotherapy [Срок оценки: Baseline and at program completion (within 4 weeks of exercise completion).]
• Changes in body composition at completion of chemotherapy, including fat-free mass in pounds. [Срок оценки: Baseline and at program completion (within 4 weeks of exercise completion).]
• Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy [Срок оценки: Baseline and at program completion (within 4 weeks of exercise completion).]
• Changes in Functional Mobility Score at baseline and at completion of chemotherapy [Срок оценки: Baseline and at program completion (within 4 weeks of exercise completion).]
• Changes in phase angle at completion of chemotherapy [Срок оценки: At program completion (at 24 weeks)]

Критерии участия

Критерии включения

• Age 20-89 years
• Women with a biopsy proven diagnosis of invasive carcinoma of the breast.
• Women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery
• Must be able to read and understand English and consent for themselves.

Критерии исключения

• Inability to get up and down off the ground or squat body weight
• Inability to safely engage in group exercise sessions as deemed by study PI
• Severe arthritic, joint, cardiovascular, musculoskeletal, or any other condition deemed by PI to be unsafe to engage in resistance training
• Lactose intolerance
• Cow's milk or whey protein allergy
• Pregnant women
• Males

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

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Allegheny General Hospital — Pittsburgh

Идентификаторы

NCT: NCT06858449 · 2024-149-SG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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