Colorectal Cancer (CRC)NBO-ONCONCT06946004
Normobaric Oxygen Therapy in Colorectal Cancer Patients
A study testing Normobaric oxygen therapy in people with Colorectal Cancer (CRC), run by 4th Military Clinical Hospital with Polyclinic, Poland at 1 site in Poland.
Trial summary
Colorectal cancer (CRC) patients undergoing chemotherapy often experience anemia, oxidative stress, and immune suppression, significantly impacting their quality of life and treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Normobaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
4th Military Clinical Hospital
Wroclaw, 50-981
Beata Jankowska-Polańska Prof., PhD, +48 71 727 41, dyrektor@cwbk.4wsk.pl
Jacek Polański Dr, PhD
About this study
Official title: 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)
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.
Read the 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 to controlled oxygen levels aimed at reducing ox-idative stress, supporting erythropoiesis, and modulating immune function. Patients in the CRC group will undergo 10 NBO sessions across five weeks, with two sessions weekly.
Patient'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 the finalization and decompression period.
Patients' exposure to atmospheric conditions in the same NBO chamber (without normobaric conditions to provide sham-placebo intervention) 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). The primary comparator in this study is the placebo NBO group (CRC patients; n=127) for CRC patients, which serves to differentiate the specific effects of active NBO from the natural course of treatment without enhanced oxygen exposure.
The patient assessment scheme contains six visits from V0 to V5 with subsequent analytical packages with detailed explanation in 2.8. section. The patient assessment schedule consists of six visits, from V0 to V5, each including specific evaluations and interventions. The study begins with V0 (prequalification/screening), where patient consent is obtained, medical history is collected, and baseline data are recorded. V1 (randomization and pre-test visit) involves the initial assessments, including anemia, stress, immune, genetic markers, and patient-reported outcomes (PROMs). Following this, the first phase of the NBO intervention (sessions 1-5) takes place over five weeks. At V2 (midpoint evaluation), the same set of assessments is repeated to track progress, followed by the second phase of the NBO intervention (sessions 6-10) conducted over the next five weeks. V3 (finalization and post-test visit) marks the completion of the intervention, with a final round of primary and secondary outcome assessments. The study then proceeds with two follow-up visits: V4 (3-months post-NBO) and V5 (6-months post-NBO), where anemia, stress, immune, genetic markers, and PROMs are reassessed to evaluate the long-term effects of the intervention.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Normobaric oxygen therapy
- Keywords
- colorectal cancer, normobaric oxygen therapy, chemotherapy-induced anemia, oxidative stress, immune modulation, erythropoiesis, supportive cancer care, adverse effects, stress, anxiety, depression, psychological well-being, quality of life
- Medical subject headings
- Colorectal Neoplasms, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric oxygen therapyDevice
Patient'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 therapyDevice
Patients' 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).
| Study group | Role | What they receive |
|---|---|---|
| active NBO therapy (n=127) | Experimental | Patient's exposure to NBO conditions in group 1 (aNBO) Receives: Device: Normobaric oxygen therapy |
| placebo NBO therapy (n=127) | Placebo comparator | Patients' exposure to atmospheric conditions in the same NBO chamber without normobaric conditions in group 2 (pNBO) Receives: Device: Normobaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythropoietin (EPO) concentration
Erythropoietin (EPO) concentration [mU/mL] will be measured using a quantitative immunoassay (ELISA) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
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.
Measured: From enrollment to the end of 6th month follow-up
Reticulocyte count
Reticulocyte count [% of total red blood cells] will be measured using an automated hematology analyzer at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
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.
Measured: From enrollment to the end of 6th month follow-up
Hemoglobin concentration (HGB)
Hemoglobin concentration (HGB) [g/dL] will be measured using an automated hematology analyzer at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Hematocrit
Hematocrit [%] will be measured using an automated hematology analyzer at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Serum creatinine
Serum creatinine [µmol/L] will be measured using an enzymatic assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) [mL/min/1.73 m²] will be calculated using the CKD-EPI equation at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) [IU/L] will be measured using an enzymatic assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) [IU/L] will be measured using an enzymatic assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Fasting glucose
Fasting glucose [mmol/L] will be measured using a hexokinase assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Fasting insulin
Fasting insulin [µU/mL] will be measured using an immunoassay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Lipid profile
Lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) [mmol/L] will be measured using enzymatic/colorimetric assays at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Iron metabolism (serum iron, total iron-binding capacity [TIBC]
Iron metabolism (serum iron, total iron-binding capacity [TIBC] [µmol/L], ferritin [ng/mL], vitamin B₁₂ [pg/mL]) will be measured using immunoassays at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Serum albumin
Serum albumin [g/L] will be measured using a bromcresol green assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
C-reactive protein (CRP)
C-reactive protein (CRP) [mg/L] will be measured using a high-sensitivity immunoturbidimetric assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Reactive oxygen species (ROS) level
Reactive oxygen species (ROS) level [relative fluorescence units] will be measured using a chemiluminescence assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up]
Serum cortisol
Serum cortisol [µg/dL] will be measured using a high-sensitivity immunoassay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Gamma-aminobutyric acid (GABA)
Gamma-aminobutyric acid (GABA) [µmol/L] will be measured using an enzyme-linked immunosorbent assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Dopamine
Dopamine [ng/mL] will be measured using a competitive immunoassay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Serotonin
Serotonin [ng/mL] will be measured using a competitive immunoassay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Fibrinogen
Fibrinogen [g/L] will be measured using the Clauss clotting assay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Glycated hemoglobin (HbA₁c)
Glycated hemoglobin (HbA₁c) [%] will be measured using high-performance liquid chromatography at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Dehydroepiandrosterone-sulfate (DHEA-S)
Dehydroepiandrosterone-sulfate (DHEA-S) [µg/dL] will be measured using an immunoassay at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Systolic blood pressure (SBP)
Systolic blood pressure (SBP) [mmHg] will be measured using an automated sphygmomanometer at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Diastolic blood pressure (DBP)
Diastolic blood pressure (DBP) [mmHg] will be measured using an automated sphygmomanometer at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Heart rate (HR)
Heart rate (HR) [beats per minute] will be measured using an automated sphygmomanometer at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Body mass index (BMI)
Body mass index (BMI) [kg/m²] will be calculated from measured weight and height at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Body surface area (BSA)
Body surface area (BSA) [m²] will be calculated using the Mosteller formula from measured weight and height at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Waist-to-hip ratio (WHR)
Waist-to-hip ratio (WHR) [ratio] will be calculated from measured waist and hip circumferences at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Tumor necrosis factor-α (TNF-α)
Tumor necrosis factor-α (TNF-α) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Interleukin-1β (IL-1β)
Interleukin-1β (IL-1β) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Interleukin-10 (IL-10)
Interleukin-10 (IL-10) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Monocyte chemoattractant protein-1 (MCP-1/CCL2) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Macrophage inflammatory protein-1α (MIP-1α/CCL3)
Macrophage inflammatory protein-1α (MIP-1α/CCL3) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Macrophage inflammatory protein-1β (MIP-1β/CCL4)
Macrophage inflammatory protein-1β (MIP-1β/CCL4) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Vascular endothelial growth factor A (VEGF-A)
Vascular endothelial growth factor A (VEGF-A) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Platelet-derived growth factor-BB (PDGF-BB)
Platelet-derived growth factor-BB (PDGF-BB) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Measured: From enrollment to the end of 6th month follow-up
Secondary outcomes (3)
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.
Measured: From enrollment to the end of 6th month follow-up
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.
Measured: From enrollment to the end of 6th month follow-up
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.
Measured: From enrollment to the end of 6th month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, double-blind, placebo-controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, Wroclaw University of Science and Technology (Poland), Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences (Poland), WSB Merito University in Opole (Poland), University of Applied Sciences in Nowy Sacz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946004
- Sponsor's protocol ID
- 2024/ABM/02/00007
- Acronym
- NBO-ONCO
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lin CH, Su WH, Chen YC, Feng PH, Shen WC, Ong JR, Wu MY, Wong CS. Treatment with normobaric or hyperbaric oxygen and its effect on neuropsychometric dysfunction after carbon monoxide poisoning: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Sep;97(39):e12456. doi: 10.1097/MD.0000000000012456.
PubMed 30278526Bloch Y, Belmaker RH, Shvartzman P, Romem P, Bolotin A, Bersudsky Y, Azab AN. Normobaric oxygen treatment for mild-to-moderate depression: a randomized, double-blind, proof-of-concept trial. Sci Rep. 2021 Sep 23;11(1):18911. doi: 10.1038/s41598-021-98245-9.
PubMed 34556722Kujawski S, Slomko J, Morten KJ, Murovska M, Buszko K, Newton JL, Zalewski P. Autonomic and Cognitive Function Response to Normobaric Hyperoxia Exposure in Healthy Subjects. Preliminary Study. Medicina (Kaunas). 2020 Apr 10;56(4):172. doi: 10.3390/medicina56040172.
PubMed 32290164De Bels D, Theunissen S, Devriendt J, Germonpre P, Lafere P, Valsamis J, Snoeck T, Meeus P, Balestra C. The 'normobaric oxygen paradox': does it increase haemoglobin? Diving Hyperb Med. 2012 Jun;42(2):67-71.
PubMed 22828812Saleh EAM, Al-Dolaimy F, Qasim Almajidi Y, Baymakov S, Kader M MA, Ullah MI, Abbas AHR, Khlewee IH, Bisht YS, Alsaalamy AH. Oxidative stress affects the beginning of the growth of cancer cells through a variety of routes. Pathol Res Pract. 2023 Sep;249:154664. doi: 10.1016/j.prp.2023.154664. Epub 2023 Jul 1.
PubMed 37573621Noman MZ, Hasmim M, Lequeux A, Xiao M, Duhem C, Chouaib S, Berchem G, Janji B. Improving Cancer Immunotherapy by Targeting the Hypoxic Tumor Microenvironment: New Opportunities and Challenges. Cells. 2019 Sep 14;8(9):1083. doi: 10.3390/cells8091083.
PubMed 31540045Bozzini C, Busti F, Marchi G, Vianello A, Cerchione C, Martinelli G, Girelli D. Anemia in patients receiving anticancer treatments: focus on novel therapeutic approaches. Front Oncol. 2024 Apr 2;14:1380358. doi: 10.3389/fonc.2024.1380358. eCollection 2024.
PubMed 38628673Bray F, Jemal A, Grey N, Ferlay J, Forman D. Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncol. 2012 Aug;13(8):790-801. doi: 10.1016/S1470-2045(12)70211-5. Epub 2012 Jun 1.
PubMed 22658655Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06946004
- Acronym / sponsor ID
- NBO-ONCO / 2024/ABM/02/00007
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- colorectal cancer, normobaric oxygen therapy, chemotherapy-induced anemia, oxidative stress, immune modulation, erythropoiesis, supportive cancer care, adverse effects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, PolandUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, Wroclaw University of Science and Technology (Poland), Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences (Poland), WSB Merito University in Opole (Poland), University of Applied Sciences in Nowy Sacz
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 to controlled oxygen levels aimed at reducing ox-idative stress, supporting erythropoiesis, and modulating immune function. Patients in the CRC group will undergo 10 NBO sessions across five weeks, with two sessions weekly.
Patient'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 the finalization and decompression period.
Patients' exposure to atmospheric conditions in the same NBO chamber (without normobaric conditions to provide sham-placebo intervention) 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). The primary comparator in this study is the placebo NBO group (CRC patients; n=127) for CRC patients, which serves to differentiate the specific effects of active NBO from the natural course of treatment without enhanced oxygen exposure.
The patient assessment scheme contains six visits from V0 to V5 with subsequent analytical packages with detailed explanation in 2.8. section. The patient assessment schedule consists of six visits, from V0 to V5, each including specific evaluations and interventions. The study begins with V0 (prequalification/screening), where patient consent is obtained, medical history is collected, and baseline data are recorded. V1 (randomization and pre-test visit) involves the initial assessments, including anemia, stress, immune, genetic markers, and patient-reported outcomes (PROMs). Following this, the first phase of the NBO intervention (sessions 1-5) takes place over five weeks. At V2 (midpoint evaluation), the same set of assessments is repeated to track progress, followed by the second phase of the NBO intervention (sessions 6-10) conducted over the next five weeks. V3 (finalization and post-test visit) marks the completion of the intervention, with a final round of primary and secondary outcome assessments. The study then proceeds with two follow-up visits: V4 (3-months post-NBO) and V5 (6-months post-NBO), where anemia, stress, immune, genetic markers, and PROMs are reassessed to evaluate the long-term effects of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| active NBO therapy (n=127) | Experimental | Device: Normobaric oxygen therapyPatient's exposure to NBO conditions in group 1 (aNBO) |
| placebo NBO therapy (n=127) | Placebo comparator | Device: Normobaric oxygen therapyPatients' exposure to atmospheric conditions in the same NBO chamber without normobaric conditions in group 2 (pNBO) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normobaric oxygen therapyPatient'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. | Device | active NBO therapy (n=127) |
| Normobaric oxygen therapyPatients' 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). | Device | placebo NBO therapy (n=127) |
Primary outcome
Erythropoietin (EPO) concentration
Time frame: From enrollment to the end of 6th month follow-up
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)
Time frame: From enrollment to the end of 6th month follow-up
Hypoxia-inducible factor-1α (HIF-1α) [ng/mL] will be measured using a quantitative immunoassay at V1, V2, V3, V4, and V5.
Reticulocyte count
Time frame: From enrollment to the end of 6th month follow-up
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)
Time frame: From enrollment to the end of 6th month follow-up
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.
Hemoglobin concentration (HGB)
Time frame: From enrollment to the end of 6th month follow-up
Hemoglobin concentration (HGB) [g/dL] will be measured using an automated hematology analyzer at V1, V2, V3, V4, and V5.
Hematocrit
Time frame: From enrollment to the end of 6th month follow-up
Hematocrit [%] will be measured using an automated hematology analyzer at V1, V2, V3, V4, and V5.
Serum creatinine
Time frame: From enrollment to the end of 6th month follow-up
Serum creatinine [µmol/L] will be measured using an enzymatic assay at V1, V2, V3, V4, and V5.
Estimated glomerular filtration rate (eGFR)
Time frame: From enrollment to the end of 6th month follow-up
Estimated glomerular filtration rate (eGFR) [mL/min/1.73 m²] will be calculated using the CKD-EPI equation at V1, V2, V3, V4, and V5.
Alanine aminotransferase (ALT)
Time frame: From enrollment to the end of 6th month follow-up
Alanine aminotransferase (ALT) [IU/L] will be measured using an enzymatic assay at V1, V2, V3, V4, and V5.
Aspartate aminotransferase (AST)
Time frame: From enrollment to the end of 6th month follow-up
Aspartate aminotransferase (AST) [IU/L] will be measured using an enzymatic assay at V1, V2, V3, V4, and V5.
Fasting glucose
Time frame: From enrollment to the end of 6th month follow-up
Fasting glucose [mmol/L] will be measured using a hexokinase assay at V1, V2, V3, V4, and V5.
Fasting insulin
Time frame: From enrollment to the end of 6th month follow-up
Fasting insulin [µU/mL] will be measured using an immunoassay at V1, V2, V3, V4, and V5.
Lipid profile
Time frame: From enrollment to the end of 6th month follow-up
Lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) [mmol/L] will be measured using enzymatic/colorimetric assays at V1, V2, V3, V4, and V5.
Iron metabolism (serum iron, total iron-binding capacity [TIBC]
Time frame: From enrollment to the end of 6th month follow-up
Iron metabolism (serum iron, total iron-binding capacity [TIBC] [µmol/L], ferritin [ng/mL], vitamin B₁₂ [pg/mL]) will be measured using immunoassays at V1, V2, V3, V4, and V5.
Serum albumin
Time frame: From enrollment to the end of 6th month follow-up
Serum albumin [g/L] will be measured using a bromcresol green assay at V1, V2, V3, V4, and V5.
C-reactive protein (CRP)
Time frame: From enrollment to the end of 6th month follow-up
C-reactive protein (CRP) [mg/L] will be measured using a high-sensitivity immunoturbidimetric assay at V1, V2, V3, V4, and V5.
Reactive oxygen species (ROS) level
Time frame: From enrollment to the end of 6th month follow-up]
Reactive oxygen species (ROS) level [relative fluorescence units] will be measured using a chemiluminescence assay at V1, V2, V3, V4, and V5.
Serum cortisol
Time frame: From enrollment to the end of 6th month follow-up
Serum cortisol [µg/dL] will be measured using a high-sensitivity immunoassay at V1, V2, V3, V4, and V5.
Gamma-aminobutyric acid (GABA)
Time frame: From enrollment to the end of 6th month follow-up
Gamma-aminobutyric acid (GABA) [µmol/L] will be measured using an enzyme-linked immunosorbent assay at V1, V2, V3, V4, and V5.
Dopamine
Time frame: From enrollment to the end of 6th month follow-up
Dopamine [ng/mL] will be measured using a competitive immunoassay at V1, V2, V3, V4, and V5.
Serotonin
Time frame: From enrollment to the end of 6th month follow-up
Serotonin [ng/mL] will be measured using a competitive immunoassay at V1, V2, V3, V4, and V5.
Fibrinogen
Time frame: From enrollment to the end of 6th month follow-up
Fibrinogen [g/L] will be measured using the Clauss clotting assay at V1, V2, V3, V4, and V5.
Glycated hemoglobin (HbA₁c)
Time frame: From enrollment to the end of 6th month follow-up
Glycated hemoglobin (HbA₁c) [%] will be measured using high-performance liquid chromatography at V1, V2, V3, V4, and V5.
Dehydroepiandrosterone-sulfate (DHEA-S)
Time frame: From enrollment to the end of 6th month follow-up
Dehydroepiandrosterone-sulfate (DHEA-S) [µg/dL] will be measured using an immunoassay at V1, V2, V3, V4, and V5.
Systolic blood pressure (SBP)
Time frame: From enrollment to the end of 6th month follow-up
Systolic blood pressure (SBP) [mmHg] will be measured using an automated sphygmomanometer at V1, V2, V3, V4, and V5.
Diastolic blood pressure (DBP)
Time frame: From enrollment to the end of 6th month follow-up
Diastolic blood pressure (DBP) [mmHg] will be measured using an automated sphygmomanometer at V1, V2, V3, V4, and V5.
Heart rate (HR)
Time frame: From enrollment to the end of 6th month follow-up
Heart rate (HR) [beats per minute] will be measured using an automated sphygmomanometer at V1, V2, V3, V4, and V5.
Body mass index (BMI)
Time frame: From enrollment to the end of 6th month follow-up
Body mass index (BMI) [kg/m²] will be calculated from measured weight and height at V1, V2, V3, V4, and V5.
Body surface area (BSA)
Time frame: From enrollment to the end of 6th month follow-up
Body surface area (BSA) [m²] will be calculated using the Mosteller formula from measured weight and height at V1, V2, V3, V4, and V5.
Waist-to-hip ratio (WHR)
Time frame: From enrollment to the end of 6th month follow-up
Waist-to-hip ratio (WHR) [ratio] will be calculated from measured waist and hip circumferences at V1, V2, V3, V4, and V5.
Tumor necrosis factor-α (TNF-α)
Time frame: From enrollment to the end of 6th month follow-up
Tumor necrosis factor-α (TNF-α) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Interleukin-1β (IL-1β)
Time frame: From enrollment to the end of 6th month follow-up
Interleukin-1β (IL-1β) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Interleukin-6 (IL-6)
Time frame: From enrollment to the end of 6th month follow-up
Interleukin-6 (IL-6) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Interleukin-10 (IL-10)
Time frame: From enrollment to the end of 6th month follow-up
Interleukin-10 (IL-10) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Time frame: From enrollment to the end of 6th month follow-up
Monocyte chemoattractant protein-1 (MCP-1/CCL2) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Macrophage inflammatory protein-1α (MIP-1α/CCL3)
Time frame: From enrollment to the end of 6th month follow-up
Macrophage inflammatory protein-1α (MIP-1α/CCL3) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Macrophage inflammatory protein-1β (MIP-1β/CCL4)
Time frame: From enrollment to the end of 6th month follow-up
Macrophage inflammatory protein-1β (MIP-1β/CCL4) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Vascular endothelial growth factor A (VEGF-A)
Time frame: From enrollment to the end of 6th month follow-up
Vascular endothelial growth factor A (VEGF-A) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
Platelet-derived growth factor-BB (PDGF-BB)
Time frame: From enrollment to the end of 6th month follow-up
Platelet-derived growth factor-BB (PDGF-BB) [pg/mL] will be measured using a multiplex immunoassay (Luminex) at V1, V2, V3, V4, and V5.
3 secondary outcomes
Stress level (self-assessment)
Time frame: From enrollment to the end of 6th month follow-up
Anxiety and depression levels (self-assessment)
Time frame: From enrollment to the end of 6th month follow-up
Quality of live level (self-assessment)
Time frame: From enrollment to the end of 6th month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 30278526Lin CH, Su WH, Chen YC, Feng PH, Shen WC, Ong JR, Wu MY, Wong CS. Treatment with normobaric or hyperbaric oxygen and its effect on neuropsychometric dysfunction after carbon monoxide poisoning: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Sep;97(39):e12456. doi: 10.1097/MD.0000000000012456.
- Background: PubMed 34556722Bloch Y, Belmaker RH, Shvartzman P, Romem P, Bolotin A, Bersudsky Y, Azab AN. Normobaric oxygen treatment for mild-to-moderate depression: a randomized, double-blind, proof-of-concept trial. Sci Rep. 2021 Sep 23;11(1):18911. doi: 10.1038/s41598-021-98245-9.
- Background: PubMed 32290164Kujawski S, Slomko J, Morten KJ, Murovska M, Buszko K, Newton JL, Zalewski P. Autonomic and Cognitive Function Response to Normobaric Hyperoxia Exposure in Healthy Subjects. Preliminary Study. Medicina (Kaunas). 2020 Apr 10;56(4):172. doi: 10.3390/medicina56040172.
- Background: PubMed 22828812De Bels D, Theunissen S, Devriendt J, Germonpre P, Lafere P, Valsamis J, Snoeck T, Meeus P, Balestra C. The 'normobaric oxygen paradox': does it increase haemoglobin? Diving Hyperb Med. 2012 Jun;42(2):67-71.
- Background: PubMed 37573621Saleh EAM, Al-Dolaimy F, Qasim Almajidi Y, Baymakov S, Kader M MA, Ullah MI, Abbas AHR, Khlewee IH, Bisht YS, Alsaalamy AH. Oxidative stress affects the beginning of the growth of cancer cells through a variety of routes. Pathol Res Pract. 2023 Sep;249:154664. doi: 10.1016/j.prp.2023.154664. Epub 2023 Jul 1.
- Background: PubMed 31540045Noman MZ, Hasmim M, Lequeux A, Xiao M, Duhem C, Chouaib S, Berchem G, Janji B. Improving Cancer Immunotherapy by Targeting the Hypoxic Tumor Microenvironment: New Opportunities and Challenges. Cells. 2019 Sep 14;8(9):1083. doi: 10.3390/cells8091083.
- Background: PubMed 38628673Bozzini C, Busti F, Marchi G, Vianello A, Cerchione C, Martinelli G, Girelli D. Anemia in patients receiving anticancer treatments: focus on novel therapeutic approaches. Front Oncol. 2024 Apr 2;14:1380358. doi: 10.3389/fonc.2024.1380358. eCollection 2024.
- Background: PubMed 22658655Bray F, Jemal A, Grey N, Ferlay J, Forman D. Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncol. 2012 Aug;13(8):790-801. doi: 10.1016/S1470-2045(12)70211-5. Epub 2012 Jun 1.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normobaric oxygen therapy in people with Colorectal Cancer (CRC), run by 4th Military Clinical Hospital with Polyclinic, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beata Jankowska-Polańska Prof., PhD (+48 71 727 41 52, dyrektor@cwbk.4wsk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythropoietin (EPO) concentration (time frame: From enrollment to the end of 6th month follow-up). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946004, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.