Colorectal CancerNCT06584318
Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer
A study testing Intermittent hypoxia intervention in people with Colorectal Cancer, run by Capital Medical University at 1 site in China.
Trial summary
This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Intermittent hypoxia intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Recent severe infection within 4 weeks.
- Received cancer treatment, including chemotherapy and radiotherapy, within 4 weeks.
- Underwent major surgery within 28 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Xunming Ji, M.D.;Ph.D.
About this study
Official title: Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer
This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Intermittent hypoxia intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hypoxia interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Participants will receive 14 times intermittent hypoxia (oxygen concentration: 13%) intervention before the surgery. Receives: Other: Intermittent hypoxia intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.
Measured: During the 7-day treatment
Secondary outcomes (5)
Tumor Markers
Blood tumor markers will be detected by the immunochemiluminescence method.
Measured: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Tumor Change
Tumor Change will be detected by tumor cell HIF-1α and HIF-2α through immunohistochemistry.
Measured: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Cytokines
Cytokines will be detected by immune-related cytokines in peripheral blood.
Measured: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Immune Cell Infiltration
Immune Cell Infiltration will be detected by observation of immune cell infiltration in tumor tissue.
Measured: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Symptoms
It is evaluated by completing the follow-up form.
Measured: The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Mar 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584318
- Sponsor's protocol ID
- IH-CC
- Status last verified
- May 2025
- First submitted
- 31 Jul 2024
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06584318
- Acronym / sponsor ID
- IH-CC
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: Intermittent hypoxia interventionParticipants will receive 14 times intermittent hypoxia (oxygen concentration: 13%) intervention before the surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent hypoxia interventionThe 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. | Other | patients |
Primary outcome
Incidence of adverse reactions
Time frame: During the 7-day treatment
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent hypoxia intervention in people with Colorectal Cancer, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, M.D. (+86-13581567815, wilma0106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: During the 7-day treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.