The effect of the addition of carbogen inhalation and nicotinamide to conventional chemotherapy for hypoxia parameters in non-Hodgkin lymphoma patients

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Participants are randomised by simple random sampling. Patients in the study arm will take nicotinamide 2 g 1 hour before chemotherapy and inhale 10 liters/min carbogen for 10 minutes on and off, starting 10 minutes before R‐CHOP chemotherapy until the finish. The control group will not receive any intervention. CONDITION: Diffuse large B‐cell lymphoma ; Cancer ; Diffuse large B‐cell lymphoma PRIMARY OUTCOME: Tumor size measured with blood oxygenation level dependent (BOLD) MRI before chemotherapy and 1 week after 1st cycle of R‐CHOP chemotherapy SECONDARY OUTCOME: ; 1. Hypoxia parameters (HIF‐1 alpha & miRNA‐210 serum) measured using ELISA and qRT PCR, respectively; 2. Angiogenesis parameters (VEGF serum) measured using ELISA; 3. Glycolytic parameters (lactate and blood gas analysis) measured using enzymatic and colorimetric methods and ion‐selective electrode, respectively; 4. Apoptotic parameters (p53, BCL‐2 serum) measured using ELISA; 5. Inflammatory parameters (TNF‐alpha, sIL‐2R serum) measured using ELISA; 6. Safety and adverse events of the intervention categorized by Common Terminology Criteria for Adverse Events (CTCAE) v6.0 and monitored during carbogen intervention and 1 day after; ; Timepoints:; Study group: measured before chemotherapy, 10 minutes after carbogen and nicotinamide, and 1 week after 1st cycle of R‐CHOP; Control group: measured before chemotherapy and 1 week after 1st cycle of R‐CHOP; INCLUSION CRITERIA: 1. DLBCL patients with increased expression of HIF‐1a (>10%) via tissue immunohistochemistry 2. Do not have anemia (hemoglobin =11 g/dl) 3. Age 18‐65 years 4. Do not have obstructive pulmonary disease (normal x‐ray thorax and spirometry) 5. No heart problems (normal electrocardiogram (ECG) and/or normal left ventricular ejection fraction (LVEF) echocardiography) 6. Have no cerebrovascular disease 7. Do not experience severe liver function problems 8. No severe renal function impairment 9. Do not suffer from diabetes mellitus (fasting blood glucose ?126 mg/dl or random blood glucose <200 mg/dl)
Epistemonikos ID: fcd7b171d2a33074330463907e2e46536305fd40
First added on: Aug 25, 2024