An open-label, randomized, controlled trial of the benefit of HMB, L-arginine, L-glutamine combination beverages and locomotion training as supportive care in the treatment of lenvatinib for unresectable advanced hepatocellular carcinoma
- Conditions
- Hepatocellular carcinomaHepatocellular carcinoma, HMB, Arginine, Glutamine, locomotion training, lenvatinib, supportive careD006528
- Registration Number
- JPRN-jRCTs031190252
- Lead Sponsor
- aganuma Atsushi
- Brief Summary
The standard first line therapy was changed from lenvatinib to the combination of atezolizumab and bevacizumab during the trial, resulting in a dramatic drop in the number of patients entered, with only 20 patients enrolled. Because of these reasons, the incidence of hand-foot syndrome, the primary endpoint of the study, was not significantly different among the 20 patients enrolled in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
(1) Age at the time of obtaining consent is over 20 years old, regardless of gender
(2) When dynamic CT or contrast-enhanced MRI shows typical imaging findings for hepatocellular carcinoma or histologically diagnoses as hepatocellular carcinoma with moderate differentiation or lower. Use AASLD criteria to diagnose hepatocellular carcinoma
(3) Unresectable liver, no indication of radiofrequency ablation, TACE refractory case
(4) Administration of lenvatinib is scheduled based on the physician
(5) Existence of measurable lesion
(6) Liver function is maintained (Child-Pugh class A and serum albumin 2.8g / dl or more, total bilirubin 3.0mg / dl or less, GOT and GPT within 5 times the standard value)
(7) ECOG PS is 0-1
(8) Even patients using BCAA are allowed to enter if the information is registered
(9) Patients receiving lenvatinib as a second-line therapy in atezolizumab plus bevacizumab
(1) Contrast CT / MRI cannot be performed due to renal dysfunction or contrast medium allergy, etc., and the therapeutic effect cannot be determined
(2) There is a history of treatment with sorafenib or regorafenib and hand foot skin reaction is not completely cured
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event grades of hand foot skin reaction (HFSR)
- Secondary Outcome Measures
Name Time Method Withdrawal period and reduction of lenvatinib<br>Skeletal muscle mass<br>Grip strength<br>QOL evaluation by SF-8TM<br>Adverse event grades of fatigue and diarrhea<br>RR and DCR<br>NH3 level and coma classification of hepatic encephalopathy