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Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03069820
Recruitment Status : Unknown
Verified February 2017 by Second Affiliated Hospital of Nanchang University.
Recruitment status was:  Recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Liver Injury, Drug-Induced Drug: docetaxel and cisplatin Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury After Therapy With Docetaxel and Cisplatin for Nasopharyngeal Carcinoma
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Population
Patients with advanced nasopharyngeal carcinoma scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy
Drug: docetaxel and cisplatin
Patients receive TP (docetaxel and cisplatin) chemotherapy
Other Name: Taxotere




Primary Outcome Measures :
  1. Relationship of white blood cell level and chemotherapy-induced liver injury [ Time Frame: 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.

  2. Relationship of albumin level and chemotherapy-induced liver injury [ Time Frame: 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.

  3. Relationship of hemoglobin level and chemotherapy-induced liver injury [ Time Frame: 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.

  4. Relationship of blood platelet level and chemotherapy-induced liver injury [ Time Frame: 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.


Secondary Outcome Measures :
  1. Relationship of age and chemotherapy-induced liver injury [ Time Frame: 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.

  2. Relationship of height and chemotherapy-induced liver injury [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069820


Contacts
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Contact: Long Huang, MD 13699549060 huanglongdoctor@163.com

Locations
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China, Jiangxi
The Second Afiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Anwen Liu, MD    13767120022    awliu666@163.com   
Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University
Investigators
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Study Director: Long Huang, MD The Second Afiliated Hospital of Nanchang University
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Responsible Party: Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT03069820    
Other Study ID Numbers: HL001
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Wounds and Injuries
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action