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Tests oxygen breathing therapy in colorectal cancer patients receiving chemotherapy

Tests normobaric oxygen therapy, compared with placebo, in adults with colorectal cancer on chemotherapy.

Key facts

Who runs it
4th Military Clinical Hospital with Polyclinic, Poland
Where
Wroclaw, PolandSee the site
Trial code
Registry title
Normobaric Oxygen Therapy in Colorectal Cancer Patients
Status
Not yet recruiting
People taking part
254 people, planned
Started
1 Nov 2025
Expected to end
1 Nov 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Normobaric oxygen therapy
Record updated
27 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stage II-IV colorectal cancer who are about to start standard chemotherapy. It tests oxygen therapy at normal air pressure.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Colorectal cancer, stage II-IV, scheduled for standard chemotherapy. ECOG performance status 0-2. Life expectancy of at least 12 months.
Earlier treatment
No other investigational therapy within the last 30 days.
Biomarker or test result
Hemoglobin above 10 g/dL at the start. Liver and kidney tests must show adequate organ function.

Main reasons for not taking part

  • Severe heart or lung conditions, such as unstable angina, recent heart attack or advanced COPD
  • Severe anemia (hemoglobin below 10 g/dL) or a hemolytic disorder
  • Uncontrolled diabetes (for example HbA1c above 8.0% (64 mmol/mol))
  • Pregnancy or breastfeeding
  • Autoimmune or inflammatory conditions that change immune responses, or a condition that rules out oxygen therapy, such as epilepsy or seizures

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • participation in other investigational therapies within the last 30 days; (9) lack of written informed consent for study participation
  • 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)
  • 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 under 18 years or over 80 years
  • pregnancy or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in Poland

  • 4th Military Clinical HospitalWroclaw, PolandContact: Beata Jankowska-Polańska Prof., PhDNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • active NBO therapy (n=127)Treatment being tested

    Patient's exposure to NBO conditions in group 1 (aNBO)

    Treatment: Normobaric oxygen therapy

  • placebo NBO therapy (n=127)Placebo, for comparison

    Patients' exposure to atmospheric conditions in the same NBO chamber without normobaric conditions in group 2 (pNBO)

    Treatment: Normobaric oxygen therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests oxygen breathing therapy in colorectal cancer patients receiving chemotherapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06946004, who can take part
Record updated
27 April 2025