Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury

Phase 4

• Conditions: Liver Injury, Drug-Induced
• Interventions: Drug: docetaxel and cisplatin

• Registration Number: NCT03069820
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

Brief Summary

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).

Detailed Description

Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in southern China , with an annual incidence of 15 to 50 cases per 100,000 people. NPC is both radiosensitive and chemosensitive. Recently, many new drugs including docetaxel and cisplatin have been incorporated in the induction chemotherapy phase of NPC. The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury, and appropriate management of these toxicities can help patients improve tolerance for chemotherapy. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, it is important to determine the risk factors to predict chemotherapy-induced liver injury. 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).

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-10
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Population	docetaxel and cisplatin	Patients with advanced nasopharyngeal carcinoma scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy

Primary Outcome Measures

Name	Time	Method
Relationship of white blood cell level and chemotherapy-induced liver injury	3 weeks	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.
Relationship of albumin level and chemotherapy-induced liver injury	3 weeks	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.
Relationship of blood platelet level and chemotherapy-induced liver injury	3 weeks	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.
Relationship of hemoglobin level and chemotherapy-induced liver injury	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Relationship of age and chemotherapy-induced liver injury	3 weeks	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.
Relationship of height and chemotherapy-induced liver injury	3 weeks	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.

Trial Locations

Locations (1)

The Second Afiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China