Normobaric Oxygen Therapy in Colorectal Cancer Patients

Launched by 4TH MILITARY CLINICAL HOSPITAL WITH POLYCLINIC, POLAND · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Normobaric Oxygen (NBO) therapy in patients with colorectal cancer (CRC) who are receiving chemotherapy. Chemotherapy can cause several challenges, such as anemia (low red blood cells), increased oxidative stress (which can harm cells), and a weakened immune system. The trial aims to see if NBO therapy can help improve red blood cell production, reduce oxidative stress, and enhance immune function, which may lead to a better quality of life for these patients. The researchers will also look at how this therapy affects stress, anxiety, and overall well-being.

To take part in this study, participants need to be between 18 and 80 years old, diagnosed with stage II-IV colorectal cancer, and scheduled for standard chemotherapy. They should have a certain level of hemoglobin (a protein in red blood cells) and be in reasonable health to participate. Over five weeks, participants will receive either the active NBO therapy or a placebo (a treatment without active ingredients) in a series of ten sessions. Throughout the study, researchers will check participants' health through various tests and follow-up visits. This trial could potentially lead to new supportive therapies for colorectal cancer patients undergoing chemotherapy, improving their treatment experience and outcomes.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).