Prevention of asparaginase-associated pancreatitis in children with acute lymphoblastic leukemia Cancer
Conditions
Interventions
After completing screening measurements and acquiring written informed consent, children participating in this study will receive 3600 unit vitamin A orally per day for 30 days. The dosage will be adj
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. One month< age =18 years 2. Diagnosis with acute lymphoblastic leukemia, which was confirmed by cell morphology, immunology, cytogenetics and molecular biology
Exclusion criteria
Exclusion criteria: 1. Previous history of pancreatitis or other conditions that may lead to pancreatitis (such as hyperlipidemia, hypercholesterolemia, and cholelithiasis) 2. Treatment course delays of more than two weeks due to financial issues 3. Exclusion of cases where acute pancreatitis occurs without the use of PEG-asparaginase (PEG-ASP) 4. The patient switching from PEG-ASP to L-ASP or Erwinia-ASP treatment due to adverse reactions other than AAP 5. Expected hospital stay of less than 2 days 6. Use of vitamin A supplements prior to enrollment within 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of asparaginase-associated pancreatitis within 60 days after enrollment measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of elevated blood amylase within 30 days of enrollment: blood amylase levels are routinely monitored twice weekly for 30 days after the use of asparaginase. Any value above the normal range at any monitoring point is defined as elevated. 2. Length of Hospital Stay: the duration from enrollment to discharge measured using patient records. 3. 28-Day Mortality after enrollment measured using patient records 4. The vitamin A levels monitoring: the plasma vitamin A levels is monitored at enrollment, and 1, 2, 3, 4 and 6 weeks after enrollment. 5. Duration of Enteral Nutrition Interruption within 60 days of enrollment measured using patient records. 6. Prothrombin time, International Normalized Ratio, Activated partial thromboplastin time, fibrinogen, AT-III, albumin levels within 30 days after enrollment. 7. Cumulative use of plasma within 30 days after enrollment. | — |
Countries
China
Contacts
Public ContactShaoyan;Zhenjiang Hu;Bai
;
Outcome results
None listed