Liver Injury, Drug-Induced Clinical Trial
Official title:
Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury After Therapy With Docetaxel and Cisplatin for Nasopharyngeal Carcinoma
The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, the investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | January 1, 2018 |
| Est. primary completion date | January 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Patients with advanced nasopharyngeal carcinoma. - Patients scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy. - Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment. - Minimum age of 18 years. - Life expectancy at least 3 months. Exclusion Criteria: - Patients previously received chemotherapy - Patients who have liver metastases. - Patients who take other drugs that may affect liver function |
| Country | Name | City | State |
|---|---|---|---|
| China | The Second Afiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| Lead Sponsor | Collaborator |
|---|---|
| Second Affiliated Hospital of Nanchang University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relationship of white blood cell level and chemotherapy-induced liver injury | White blood cell level (cells/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of white cell level fluctuation and liver injury will be investigated. | 3 weeks | |
| Primary | Relationship of albumin level and chemotherapy-induced liver injury | Albumin (g/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of albumin fluctuation and liver injury will be investigated. | 3 weeks | |
| Primary | Relationship of hemoglobin level and chemotherapy-induced liver injury | Hemoglobin (g/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of hemoglobin fluctuation and liver injury will be investigated. | 3 weeks | |
| Primary | Relationship of blood platelet level and chemotherapy-induced liver injury | Blood platelet (cells/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of blood platelet fluctuation and liver injury will be investigated. | 3 weeks | |
| Secondary | Relationship of age and chemotherapy-induced liver injury | The age(years) will be recorded when the therapy starts. The liver function (such as ALT, AST, ALP, and bilirubin levels) will betested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy. The relationship of age and liver injury will be investigated. | 3 weeks | |
| Secondary | Relationship of height and chemotherapy-induced liver injury | The height (kg) will be recorded when the therapy starts. The liver function (such as ALT, AST, ALP, and bilirubin levels) will betested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy. The relationship of height and liver injury will be investigated. | 3 weeks |