Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Other: Intermittent hypoxia intervention
- Registration Number
- NCT06584318
- Lead Sponsor
- Capital Medical University
- Brief Summary
This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patients Intermittent hypoxia intervention Participants will receive 14 times intermittent hypoxia (oxygen concentration: 13%) intervention before the surgery.
- Primary Outcome Measures
Name Time Method Incidence of adverse reactions During the 7-day treatment Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.
- Secondary Outcome Measures
Name Time Method Tumor Markers The day before the 7-day treatment ; the day of surgery (1-7days post the treatment) Blood tumor markers will be detected by the immunochemiluminescence method.
Tumor Change The day before the 7-day treatment ; the day of surgery (1-7days post the treatment) Tumor Change will be detected by tumor cell HIF-1α and HIF-2α through immunohistochemistry.
Cytokines The day before the 7-day treatment ; the day of surgery (1-7days post the treatment) Cytokines will be detected by immune-related cytokines in peripheral blood.
Immune Cell Infiltration The day before the 7-day treatment ; the day of surgery (1-7days post the treatment) Immune Cell Infiltration will be detected by observatiion of immune cell infiltration in tumor tissue.
Symptoms The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery It is evaluated by completing the follow-up form.
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China