Exploratory Study of Intermittent Hypoxia Intervention on Colorectal 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: Intermittent hypoxia intervention.
- Кому может быть актуально
- Состояния в реестре: Colorectal Cancer. Базовые параметры: 18 лет — 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
- Китай
- 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
Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer
Обзор
This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.
Подробное описание
The hypoxic adaptive response is a form of acquired tolerance that occurs by activating internal cellular protective mechanisms and enhancing immune function.This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia. This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia.
Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused by hypoxia. Intermittent hypoxia has been shown in our team's work to effectively inhibit colorectal cancer tumor progression in mice by enhancing immune cell function. This study aims to explore the safety and efficacy of IH in patients with colorectal cancer using a non-randomized self-controlled trial.
Вмешательства
- Другое Intermittent hypoxia intervention
The intermittent hypoxia protocol refers to 6 cycles of 10 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.
Первичные конечные точки
- Incidence of adverse reactions [Срок оценки: During the 7-day treatment]
Вторичные конечные точки (5)
- Tumor Markers [Срок оценки: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Tumor Change [Срок оценки: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Cytokines [Срок оценки: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Immune Cell Infiltration [Срок оценки: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Symptoms [Срок оценки: The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery]
Критерии участия
Критерии включения
- Patients with colorectal cancer between ages of 18 and 65 years.
- Colorectal cancer stage Ⅰ,Ⅱ.
- Subjects or their legally authorized representative can provide informed consent.
Критерии исключения
- History of cardiovascular, cerebrovascular, dermatological, and hematological diseases.
- History of pulmonary, hepatic, kidney, dermatologic and hematologic diseases.
- History of pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
- History of substance abuse.
- Participating in other drug or medical device studies.
- History of organ transplantation, including allogeneic stem cell and immune cell transplantation.
- Recent severe infection within 4 weeks.
- Received cancer treatment, including chemotherapy and radiotherapy, within 4 weeks.
- Underwent major surgery within 28 days.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Китай · 1 центр
- Xuanwu Hospital, Capital Medical University — Пекин
Идентификаторы
NCT: NCT06584318 · IH-CC