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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XSLJZ | Experimental | Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid |
|
| XSLJZ Placebo | Placebo Comparator | 10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiang Sha Liu Jun Zi Decoction dry powder | Drug | the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight | patient body weight | 8 weeks |
| EORTC QLQ-C30 score | European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score | 8 weeks |
| EORTC QLQ-HCC18 | European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score | 8 weeks |
| CASQ | cancer appetite and symptom questionnaire | 8 weeks |
| FACT-G | Functional Assessment of Cancer Therapy - General | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CCMQ | Chinese medicine questionnaire | 8 weeks |
| tong diagnosis | tong diagnosis by Automatic Tongue Diagnosis System | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YuanChing Liao | China Medial University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University hospital | Taichung | 西屯區 | 407 | Taiwan |
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| XSLJZ Placebo | Drug | XSLJZ Placebo |
|
| pulse diagnosis | pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters | 8 weeks |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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