Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent hypoxia intervention.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Incidence of adverse reactions [Time frame: During the 7-day treatment]
Secondary outcome measures (5)
- Tumor Markers [Time frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Tumor Change [Time frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Cytokines [Time frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Immune Cell Infiltration [Time frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)]
- Symptoms [Time frame: The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06584318 · IH-CC