Clinical trial NCT06584318: Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer
Official title: Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: During the 7-day treatment
Secondary outcomes:
measure: Tumor Markers
timeFrame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
measure: Tumor Change
timeFrame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
measure: Cytokines
timeFrame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
measure: Immune Cell Infiltration
timeFrame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
measure: Symptoms
timeFrame: The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: