Status:
NOT_YET_RECRUITING
Normobaric Oxygen Therapy in Colorectal Cancer Patients
Lead Sponsor:
4th Military Clinical Hospital with Polyclinic, Poland
Collaborating Sponsors:
Wroclaw Medical University (Poland)
Wroclaw University of Science and Technology (Poland)
Conditions:
Colorectal Cancer (CRC)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Colorectal cancer (CRC) patients undergoing chemotherapy often experience anemia, oxidative stress, and immune suppression, significantly impacting their quality of life and treatment outcomes. Normob...
Detailed Description
The intervention will involve NBO as a supportive treatment for CRC patients undergoing chemotherapy. The NBO protocol consists of regular sessions in a normobaric chamber where patients are exposed t...
Eligibility Criteria
Inclusion
- age between 18 and 80 years (participants must be adults)
- diagnosed with CRC (stage II-IV, scheduled for standard chemotherapy (for study and control groups)
- baseline hemoglobin levels above 10 g/dL
- no concurrent hematologic malignancies
- eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (ensuring participants are ambulatory and capable of self-care)
- life expectancy of at least 12 months (participants are expected to survive the duration of the study)
- ability and willingness to comply with all study procedures and schedules (including NBO therapy sessions and follow-up visits)
- adequate organ function as determined by laboratory tests (liver function tests - ALT, AST), renal function tests (serum creatinine, eGFR)
- women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use effective contraception during the study (to ensure safety for potential pregnancies)
- written informed consent obtained prior to any study-related procedures (participants must understand and agree to all aspects of the study).
Exclusion
- age under 18 years or over 80 years
- severe cardiovascular or respiratory conditions (e.g., unstable angina, recent myocardial infarction, advanced COPD)
- severe anemia (hemoglobin \<10 g/dL) or any hemolytic disorder that could confound study outcomes
- uncontrolled diabetes mellitus (e.g., HbA1c \>8.0% or poor glycemic control requiring frequent hospitalizations)
- pregnancy or breastfeeding
- severe infection or immunocompromised status unrelated to cancer (e.g., advanced HIV infection)
- current psychiatric or neurological disorders that could interfere with study participation
- participation in other investigational therapies within the last 30 days; (9) lack of written informed consent for study participation
- autoimmune or inflammatory conditions (e.g., lupus, rheumatoid arthritis on immunosuppressive therapy) that significantly alter immune responses
- presence of any contraindication for NBO therapy (e.g., active bleeding, acute infections, inflammation of the optic nerve, epilepsy or seizures, uncontrolled diabetes as noted above, pneumothorax, emphysema, electronic implants).
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT06946004
Start Date
November 1 2025
End Date
November 1 2028
Last Update
April 27 2025
Active Locations (1)
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1
4th Military Clinical Hospital
Wroclaw, Poland, 50-981