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NCT Number: NCT06584318

Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

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

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent hypoxia intervention

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.

Primary outcomes

  1. Incidence of adverse reactions

    Time frame: During the 7-day treatment

    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.

Secondary outcomes

  1. Tumor Markers

    Time frame: 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.

  2. Tumor Change

    Time frame: 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.

  3. Cytokines

    Time frame: 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.

  4. Immune Cell Infiltration

    Time frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)

    Immune Cell Infiltration will be detected by observation of immune cell infiltration in tumor tissue.

  5. Symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan Wang, M.D.

CONTACT

[email protected]

+86-13581567815

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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