A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
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 Therapy.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma. Базовые параметры: от 18 лет · Мужчины.
- 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
Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
Обзор
To determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on Active Surveillance for localized prostate cancer.
Подробное описание
The purpose of this study is to find out the effects of exercise therapy on indicators of prostate cancer in people with low-risk prostate cancer who are on active surveillance. The exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist (a medical professional who studies how exercise affects the human body). Some participants in this study will have the assigned exercise therapy, and some participants will participate in their usual exercise routines. Researchers will compare how the assigned exercise therapy and the usual exercise routines affect indicators of prostate cancer in participants. This study will not provide treatment for prostate cancer.
Вмешательства
- Поведенческое Exercise Therapy
The intervention will consist of exercise therapy, individualized, walking delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule, up to 5 individual treatment sessions/week to achieve a cumulative total duration of 225 to 300 mins/wk until the participant's next standard of care prostate biopsy (about 6-12 months).
Первичные конечные точки
- Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up [Срок оценки: 6-12 months]
Критерии участия
Критерии включения
- Age ≥ 18
- Men with histologically confirmed localized prostate cancer undergoing active surveillance.
- Inactive, defined as not meeting the national exercise guidelines for cancer patients (<150 minutes/week of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch).
- Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG)
- BMI <40 kg/m\^2
- Cleared for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (Appendix B)
Критерии исключения
- Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)
- Any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years
- Any history of systemic anticancer therapy in the last 15 years
- Distant metastatic malignancy of any kind
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 10 центров
- City of Hope Medical Center — Durate
- University of California, Los Angeles (Data and Specimen Analysis Only) — Los Angeles
- Hartford Healthcare Alliance (Data collection only) — Hartford
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) — Commack
- Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison
- … и ещё 2 центра
Идентификаторы
NCT: NCT05751434 · 25780