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

The effect of the addition of carbogen inhalation and nicotinamide to conventional chemotherapy against hypoxia, angiogenesis, apoptotic pathway, glycolytic metabolism, and inflammatory pathway parameters in diffuse large B-cell lymphoma patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77237304

Enrollment

Registered

2021-06-14

Start date

2021-07-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell lymphoma Cancer Diffuse large B-cell lymphoma

Interventions

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, sta

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) =2 2. Pregnancy before or while undergoing chemotherapy 3. History of chemotherapy for non-Hodgkin lymphoma (NHL) cases before 4. Allergic reaction to chemotherapy treatment

Design outcomes

Primary

Measure	Time frame
Tumor size measured with blood oxygenation level dependent (BOLD) MRI before chemotherapy and 1 week after 1st cycle of R-CHOP chemotherapy	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026