Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury

• Sponsor: Second Affiliated Hospital of Nanchang University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03069820
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.7
• Patients Per Site Per Month: 11.2

Study Details

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).

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).

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 10, 2017
• Anticipated Primary Completion Date: Jan 1, 2018
• Anticipated Study Completion Date: Jan 1, 2018

Arms and Interventions

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 Names: Taxotere

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Afiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006

Sponsors and Collaborators

• Second Affiliated Hospital of Nanchang University

Investigators

• Study Director: Long Huang, MD, The Second Afiliated Hospital of Nanchang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital of Nanchang University
• ClinicalTrials.gov Identifier: NCT03069820
• Other Study ID Numbers: HL001
• First Posted: Mar 3, 2017
• Last Update Posted: Mar 3, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chemical and Drug Induced Liver Injury; Wounds and Injuries; Docetaxel

Study Results

No Results Posted as of Mar 3, 2017