Clinical trial NCT03069820: Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury
Official title: Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury After Therapy With Docetaxel and Cisplatin for Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Injury, Drug-Induced
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

Eligibility criteria: 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

Primary outcomes:
measure: Relationship of white blood cell level and chemotherapy-induced liver injury
timeFrame: 3 weeks
measure: Relationship of albumin level and chemotherapy-induced liver injury
timeFrame: 3 weeks
measure: Relationship of hemoglobin level and chemotherapy-induced liver injury
timeFrame: 3 weeks
measure: Relationship of blood platelet level and chemotherapy-induced liver injury
timeFrame: 3 weeks
Secondary outcomes:
measure: Relationship of age and chemotherapy-induced liver injury
timeFrame: 3 weeks
measure: Relationship of height and chemotherapy-induced liver injury
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Afiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The Second Afiliated Hospital of Nanchang University
name: Long Huang, MD
role: STUDY_DIRECTOR
References: