Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Capital Medical University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of adverse reactions
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Incidence of adverse reactions
Time Frame: During the 7-day treatment
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.
Secondary Outcomes
- Tumor Change(The day before the 7-day treatment ; the day of surgery (1-7days post the treatment))
- Cytokines(The day before the 7-day treatment ; the day of surgery (1-7days post the treatment))
- Symptoms(The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery)
- Tumor Markers(The day before the 7-day treatment ; the day of surgery (1-7days post the treatment))
- Immune Cell Infiltration(The day before the 7-day treatment ; the day of surgery (1-7days post the treatment))