An open-label, randomized, controlled trial on the benefit of β-hydroxy-β-methyl butyrate, l-arginine, l-glutamine combination beverages and locomotion training as supportive care for the treatment of unresectable hepatocellular carcinoma using lenvatinib: A pilot study (HELLO study).

2025-02
Clinical nutrition ESPEN 65
- Atsushi Naganuma
- Fujio Makita
- Rie Sugimoto
- Masahiro Kikuchi
- Kiyoshi Furuta
- Satoru Iwamoto
- Ryotaro Sakamori
- Hirotaka Kouno
- Keisuke Ario
- Hiroshi Yatsuhashi

PubMed: 39675424
DOI: 10.1016/j.clnesp.2024.12.005

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 20
Population: 20 patients with unresectable hepatocellular carcinoma (uHCC)
Methods: randomized controlled trial (RCT) of the efficacy of a β-hydroxy-β-methyl butyrate/l-arginine/l-glutamine (HMB/Arg/Gln) beverage and locomotion training as supportive care

Introduction

Hand-foot-skin reaction (HFSR) is the most common side effect of multi-tyrosine kinase inhibitor therapy for unresectable hepatocellular carcinoma (uHCC). Sarcopenia has been reported to be a poor prognostic factor for HCC. Here, we performed a randomized controlled trial (RCT) of the efficacy of a β-hydroxy-β-methyl butyrate/l-arginine/l-glutamine (HMB/Arg/Gln) beverage and locomotion training as supportive care in the treatment of uHCC with lenvatinib.

Methods

A total of 20 patients were enrolled from the jRCTs031190252 trial in this pilot study. HFSR was the primary endpoint, and other adverse events and skeletal muscle index at the third lumbar level (L3-SMI) were secondary endpoints.

Results

Twelve patients had albumin-bilirubin grade 1, and eight had grade 2. No difference in HFSR was observed. Although interesting differences were observed in the secondary endpoints, a slight retention of L3-SMI values in the intervention group compared with that in the control group was observed (96.5 % vs. 89.9 %, p = 0.407).

Conclusion

Although the HMB/Arg/Gln beverage and locomotion training did not reduce adverse events caused by lenvatinib, they might be useful in maintaining skeletal muscle mass. Further validation studies with a larger number of patients are warranted.

Research Insights

L-Arginine→Preserved Skeletal Muscle Index
a slight retention of L3-SMI values in the intervention group compared with that in the control group was observed (96.5 % vs. 89.9 %, p = 0.407).
Effect
Beneficial
Effect size
Small
L-Glutamine→Preserved Skeletal Muscle Index
a slight retention of L3-SMI values in the intervention group compared with that in the control group was observed (96.5 % vs. 89.9 %, p = 0.407).
Effect
Beneficial
Effect size
Small