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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
XSLJZ Placebo
China Medical University hospital
Taichung, 西屯區, Taiwan
body weight
patient body weight
Time frame: 8 weeks
EORTC QLQ-C30 score
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score
Time frame: 8 weeks
EORTC QLQ-HCC18
European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score
Time frame: 8 weeks
CASQ
cancer appetite and symptom questionnaire
Time frame: 8 weeks
FACT-G
Functional Assessment of Cancer Therapy - General
Time frame: 8 weeks
CCMQ
Chinese medicine questionnaire
Time frame: 8 weeks
tong diagnosis
tong diagnosis by Automatic Tongue Diagnosis System
Time frame: 8 weeks
pulse diagnosis
pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters
Time frame: 8 weeks
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TREATMENT
Masking
QUADRUPLE
Enrollment
10