Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
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: Prehabilitation.
- Кому может быть актуально
- Состояния в реестре: Ovarian Cancer, Epithelial Ovarian Cancer, Pancreatic Adenocarcinoma. Базовые параметры: от 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- 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
Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
Обзор
The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
Подробное описание
Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.
Вмешательства
- Другое Prehabilitation
Exercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The exercise session will consist of a program that adheres to the FITT (Frequency, Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM Roundtable recommendations for Physical Function for combined Aerobic and Resistance training. Nutrition Intervention: 30 gm protein supplement Supportive car
Первичные конечные точки
- Rate of adherence as calculated by the compliance percentage [Срок оценки: 6 weeks post intervention]
Вторичные конечные точки (12)
- Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test [Срок оценки: Baseline, 6 weeks post intervention]
- Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test. [Срок оценки: Baseline, 6 weeks post intervention]
- Change in effectiveness of prehabilitation as assessed by timed up and go test [Срок оценки: Baseline, 6 weeks post intervention]
- Change in effectiveness of prehabilitation as assessed by grip strength test [Срок оценки: Baseline, 6 weeks post intervention]
- Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test [Срок оценки: Baseline, 6 weeks post intervention]
- Change in measure of balance as assessed by unipedal stance test [Срок оценки: Baseline, 6 weeks post intervention]
- Effectiveness of prehabilitation as assessed by measuring the change in body mass composition [Срок оценки: Baseline, 6 weeks post-intervention]
- Effectiveness of prehabilitation as assessed by the change in nutritional status [Срок оценки: Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention]
- Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) [Срок оценки: At baseline]
- Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) [Срок оценки: Up to 6 weeks post intervention]
- Quality of life as assessed by FACT-O [Срок оценки: At baseline]
- Quality of life as assessed by FACT-O [Срок оценки: Up to 6 weeks post intervention]
Критерии участия
Критерии включения
- Age 65 and older
- Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or
- Patients with diagnosis of pancreatic adenocarcinoma (PDAC) (Stage I, II, or III) undergoing neoadjuvant chemotherapy.
- Patients with locally advanced esophageal cancer undergoing neoadjuvant chemotherapy.
- Patients with locally advanced muscle invasive bladder cancer undergoing neoadjuvant chemotherapy.
Критерии исключения
- Life expectancy less than 3 months in the opinion of the treating physician
- Patients unable to provide informed consent.
- Wheelchair bound patients/ physical immobility.
- Severe cardiopulmonary disease defined as NYHA class III or IV
- Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded.
- Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland
Идентификаторы
NCT: NCT06412510 · CASE3824