NCT06946004Not yet recruiting
Normobaric Oxygen Therapy in Colorectal Cancer Patients
The Potential of Normobaric Oxygen Therapy to Enhance Erythropoiesis, Reduce Oxidative Stress, and Modulate Immune Function in Colorectal Cancer Patients Undergoing Chemotherapy: Study Protocol for a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial (NBO-ONCO)
Source: ClinicalTrials.gov · Last updated 27 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Colorectal cancer (CRC) patients undergoing chemotherapy often experience anemia, oxidative stress, and immune suppression, significantly impacting their quality of life and treatment outcomes. Normobaric oxygen (NBO) therapy, which delivers oxygen at atmospheric pressure with elevated oxygen concentration, has shown a potential to enhance erythropoiesis, reduce oxidative stress, and modulate immune function. However, its efficacy in CRC patients remains underexplored. This study aims to evaluate the effects of NBO exposures on (1) supporting erythropoiesis by measuring erythropoietin (EPO) levels and hypoxia-inducible factors (HIF-1α), (2) reducing oxidative stress and improving stress and emotional well-being, and (3) modulating immune function by assessing cytokine profiles. Secondary objectives include assessing the impact of NBO on patient-reported outcome measures (PROMs) such as stress, anxiety, depression, and quality of life. This is a prospective, randomized, double-blind, placebo-controlled clinical trial. A total of 254 CRC patients undergoing chemotherapy will be randomized 1:1 to receive either active NBO therapy (n=127) or placebo NBO therapy (n=127). The intervention consists of 10 NBO sessions over five weeks. Primary outcomes include biomarkers of erythropoiesis, oxidative stress, and immune response. Secondary outcomes assess quality of life and psychological well-being. Data will be collected at baseline, mid-intervention, post-intervention, and during two follow-up visits (3- and 6-months post-intervention). The study hypothesizes that NBO therapy will improve erythropoiesis, reduce oxidative stress, and enhance immune function in CRC patients, leading to improved quality of life and clinical outcomes. Findings from this trial may establish NBO as a novel supportive therapy for CRC patients undergoing chemotherapy.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 254 (estimated)
- First submitted
- 10 Apr 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
- Diseases
- Colorectal cancer
- NCT number
- NCT06946004
What you commit to
- Study type: Interventional
- Planned participants: 254
- From 1 Nov 2025 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participation in other investigational therapies within the last 30 days; (9) lack of written informed consent for study participation
Other illness
- severe cardiovascular or respiratory conditions (e.g., unstable angina, recent myocardial infarction, advanced COPD)
- severe infection or immunocompromised status unrelated to cancer (e.g., advanced HIV infection)
- current psychiatric or neurological disorders that could interfere with 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).
Lab values
- 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)
Age
- age under 18 years or over 80 years
Other
- pregnancy or breastfeeding
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 4th Military Clinical Hospital Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.