Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer

NCT ID: NCT06584318

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-04-30

Brief Summary

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This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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patients

Participants will receive 14 times intermittent hypoxia (oxygen concentration: 13%) intervention before the surgery.

Group Type EXPERIMENTAL

Intermittent hypoxia intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Wang, M.D.

Role: CONTACT

+86-13581567815

Facility Contacts

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Xunming Ji, M.D.;Ph.D.

Role: primary

Other Identifiers

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IH-CC

Identifier Type: -

Identifier Source: org_study_id

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