Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury
Primary Purpose
Liver Injury, Drug-Induced
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
docetaxel and cisplatin
Sponsored by
About this trial
This is an interventional screening trial for Liver Injury, Drug-Induced
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
Sites / Locations
- The Second Afiliated Hospital of Nanchang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Population
Arm Description
Patients with advanced nasopharyngeal carcinoma scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03069820
First Posted
February 13, 2017
Last Updated
February 27, 2017
Sponsor
Second Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT03069820
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Anticipated)
Study Completion Date
January 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Injury, Drug-Induced
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Population
Arm Type
Experimental
Arm Description
Patients with advanced nasopharyngeal carcinoma scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Other Intervention Name(s)
Taxotere
Intervention Description
Patients receive TP (docetaxel and cisplatin) chemotherapy
Primary Outcome Measure Information:
Title
Relationship of white blood cell level and chemotherapy-induced liver injury
Description
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.
Time Frame
3 weeks
Title
Relationship of albumin level and chemotherapy-induced liver injury
Description
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.
Time Frame
3 weeks
Title
Relationship of hemoglobin level and chemotherapy-induced liver injury
Description
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.
Time Frame
3 weeks
Title
Relationship of blood platelet level and chemotherapy-induced liver injury
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Relationship of age and chemotherapy-induced liver injury
Description
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.
Time Frame
3 weeks
Title
Relationship of height and chemotherapy-induced liver injury
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Huang, MD
Phone
13699549060
Email
huanglongdoctor@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Huang, MD
Organizational Affiliation
The Second Afiliated Hospital of Nanchang University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Afiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anwen Liu, MD
Phone
13767120022
Email
awliu666@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury
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