Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer

NCT06584318 | Recruiting

• 1 other identifier: IH-CC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

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

  During the 7-day treatment

Secondary Outcomes (5)

• Tumor Markers

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

• Tumor Change

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

• Cytokines

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

• Immune Cell Infiltration

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

• Symptoms

  The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery

Study Arms (1)

patients

EXPERIMENTAL

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

Other: Intermittent hypoxia intervention

Interventions

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.

patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yuan Wang, M.D.

CONTACT

+86-13581567815; wilma0106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: September 4, 2024
• Study Start: March 1, 2024
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)