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.
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
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)
Parallel
Normobaric oxygen therapy
DevicePatient's exposure to NBO conditions in group 1 (aNBO) including: oxygen levels of 32-40% (compared to about 21% in the atmosphere), pressure maintained at 1,500 hPa (about 1,000 hPa outside), carbon dioxide levels between 0.7-1.9% (compared to 0.03% in the atmosphere, and hydrogen levels between 0.5-1% (which is 10 to 20 thousand times higher than in the atmosphere). Exposure time in the NBO chamber will be the standard 2 hours with an additional 20 minutes for preparation and adaptation and 10 minutes for finalization and the decompression period.
Normobaric oxygen therapy
DevicePatients' exposure to atmospheric conditions in the same NBO chamber (without normobaric conditions to provide placebo intervention as the study comparator) in group 2 (pNBO): oxygen levels about 21%, pressure maintained at about 1,000 hPa, carbon dioxide levels about o 0.03%, and hydrogen levels about 0.00005% (0.5 parts per million, like in the atmos-phere).
Erythropoietin (EPO) concentration
Erythropoietin (EPO) concentration \[mU/mL\] will be measured using a quantitative immunoassay (ELISA) at V1, V2, V3, V4, and V5.
Hypoxia-inducible factor-1α (HIF-1α)
Hypoxia-inducible factor-1α (HIF-1α) \[ng/mL\] will be measured using a quantitative immunoassay at V1, V2, V3, V4, and V5.
Reticulocyte count
Reticulocyte count \[% of total red blood cells\] will be measured using an automated hematology analyzer at V1, V2, V3, V4, and V5.
Red blood cell (RBC)
Red blood cell (RBC) count \[10¹² cells/L\] will be measured using 5-part differential blood morphology on an automated hematology analyzer at V1, V2, V3, V4, and V5.
Stress level (self-assessment)
The Perceived Stress Questionnaire (PSQ-30) is a 30-item self-report instrument designed to assess perceived stress over the previous month. Each item is rated on a 4-point Likert scale (1 = "almost never" to 4 = "usually"), yielding a raw score that can range from 30 (minimum) to 120 (maximum). Higher raw scores indicate greater perceived stress (worse outcome). The PSQ-30 will be administered at V1, V2, V3, V4, and V5.
Anxiety and depression levels (self-assessment)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire comprising two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). Each subscale contains 7 items scored on a 4-point Likert scale (0 = "not at all" to 3 = "very often"), yielding subscale scores from 0 (minimum) to 21 (maximum). Higher scores indicate greater symptom severity (worse outcome). The HADS total score (sum of HADS-A and HADS-D) ranges from 0 to 42. The HADS will be administered at V1, V2, V3, V4, and V5.
Quality of live level (self-assessment)
EuroQol Five-Dimension Five-Level questionnaire (EQ-5D-5L) index score \[-0.59 to 1.00; higher = better health\] will be derived from five domains-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on a 5-point scale (1 = no problems to 5 = extreme problems). Health states will be converted to a single index value using the Polish EQ-5D-5L value set. The EQ-5D-5L will be administered at V1, V2, V3, V4, and V5.
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4th Military Clinical Hospital with Polyclinic, Poland
Lead sponsor
Wroclaw Medical University
Collaborator
Wroclaw University of Science and Technology (Poland)
Collaborator
Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences (Poland)
Collaborator
WSB Merito University in Opole (Poland)
Collaborator
Academy of Applied Sciences in Nowy Sacz (Poland)
Collaborator
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