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

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 - HELLO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190252

Enrollment

160

Registered

2020-03-16

Start date

2020-03-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma Hepatocellular carcinoma, HMB, Arginine, Glutamine, locomotion training, lenvatinib, supportive care

Interventions

HMB / Arg / Gln beverage and locomotion training will be used In patients with advanced hepatocellular carcinoma treated with lenvatinib. The intervention period is 4 months.

D046650

Hepatocellular carcinoma, HMB, Arginine, Glutamine, locomotion training, lenvatinib, supportive care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Adverse event grades of hand foot skin reaction (HFSR)	—

Secondary

Measure	Time frame
Withdrawal period and reduction of lenvatinib Skeletal muscle mass Grip strength QOL evaluation by SF-8TM Adverse event grades of fatigue and diarrhea RR and DCR NH3 level and coma classification of hepatic encephalopathy	—

Contacts

Public ContactAtsushi Naganuma

National Hospital Organization Takasaki General Medical Center

naganuma.atsushi.nj@mail.hosp.go.jp+81-27-322-5901

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026