Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT06946004
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06946004
Study Brief:
Protocol Section:
NCT06946004