Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, multiple protein kinase inhibitor therapy, Xiang Sha Liu Jun Zi Decoction, appetite
Brief summary
The purpose of the study was search the safety and efficacy of the of Xiang Sha Liu Jun Zi Decoction (XSLJZ) in advanced hepatocellular carcinoma patients with multiple protein kinase inhibitor therapy. Evaluate the treatment effect on the symptoms of appetite and quality of life in advanced hepatocellular carcinoma patients
Detailed description
Hepatocellular carcinoma (HCC) is the top fourth most common cancer in Taiwan. Approximately 85% of cases of HCC patients had chronic HBV or HCV infection in Taiwan. Metabolic risk factors, such as obesity, fatty liver, high lipidemia, and diabetes mellitus are associated with increased risk for nonviral hepatocellular carcinoma. The first and second-line systemic therapy approved in advanced hepatocellular carcinoma are multikinase inhubitors .Sorafenib (Nexavar)、Regorafenib and Lenvatinib are significantly improve survival in patients who had unresectable advanced and/or metastatic HCC not amenable to local treatment methods. General fatigue, poor appetite and pain are regarded as common and unavoidable side effect experienced during the course of cancer and its treatment. Anorexia is a common cause of malnutrition and is associated with negative effects on the quality of life (QOL) for patients with cancer. However, quality of life as a prognostic factor for survival in hepatocellular carcinoma. Management of appetite is the key to improving both the QOL and the prognosis for such patients. Cancer-related anorexia and target therapy-induced anorexia is very important in HCC patients. According to Chinese medicine theory., spleen-deficiency, qi-stagnation and dampness are the most common syndrome in advanced hepatocellular carcinoma patients. Thus, the principles of Chinese medicine treatment are invigorating Pi, regulating qi, dissipating dampness and appetizing wei. Most patients received traditional Chinese medicine treatment as adjuvant therapy to alleviate cancer symptoms, diminishing the side effects and complications of treatment course at late stages. The purpose of the study was search the safety and efficacy of the of Xiang Sha Liu Jun Zi Decoction (XSLJZ) in advanced hepatocellular carcinoma patients with multiple protein kinase inhibitor therapy. Evaluate the treatment effect on the symptoms of appetite and quality of life in advanced hepatocellular carcinoma patients
Interventions
DRUGXiang Sha Liu Jun Zi Decoction dry powder
the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
DRUGXSLJZ Placebo
XSLJZ Placebo
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Advanced hepatocellular carcinoma patient 2. use multiple protein kinase inhibitor therapy paid by National Health Care Insurance system (NHCIS) in Taiwan 3. Child-Pugh A class 4. Eastern Cooperative Oncology Group performance status of 0-2 5. survival period over 3 months 6. used Xiang Sha Liu Jun Zi Decoction for one month before the multiple protein kinase inhibitor therapystarting point
Exclusion criteria
1. combine other cancer at the same time 2. ESRD under dialysis 3. heart disease,CHF、CAD、arrhythmia、hypertension (SBP\>150mmHg，DSP\>90 mmHg) 4. current serious infection 5. GI bleeding within 30 days 6. receive organ transplant 7. Child-Pugh Class B or C liver status。 8. Refractory Ascites in Liver Cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight | 8 weeks | patient body weight |
| EORTC QLQ-C30 score | 8 weeks | European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score |
| EORTC QLQ-HCC18 | 8 weeks | European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score |
| CASQ | 8 weeks | cancer appetite and symptom questionnaire |
| FACT-G | 8 weeks | Functional Assessment of Cancer Therapy - General |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CCMQ | 8 weeks | Chinese medicine questionnaire |
| tong diagnosis | 8 weeks | tong diagnosis by Automatic Tongue Diagnosis System |
| pulse diagnosis | 8 weeks | pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters |
Countries
Taiwan
Outcome results
None listed