Opioid-based pain control and systemic oral care program are effective for the chemoradiotherapy (CRT)-induced severe oral mucositis (OM) in patients with head and neck cancers (HNC). This phase II trial assessed the clinical benefit of beta-Hydroxy-beta-Methylbutyrate, Arginine, and Glutamine (HMB/Arg/Gln) in the prevention of CRT-induced OM in patients with HNC.
Patients with HNC who were scheduled to receive definitive or postoperative cisplatin-based CRT were enrolled. HMB/Arg/Gln was administered orally or per percutaneous endoscopic gastrostomy from the first day of CRT up to completion of CRT. All patients received opioid-based pain control and oral care programs we previously published. The primary endpoint was the incidence of grade ≥3 OM (functional/symptomatic) according to the Common Terminology Criteria of Adverse Events version 3.0. QOL (EORTC QLQ-C30/PROMS) and intake of nutrition at baseline and 50Gy were also assessed.
From February 2015 to June 2016, 35 patients with HNC were enrolled. Sixteen patients (45.7%) developed grade ≥3 OM (i.e., functional/symptomatic). The incidence of grade ≤1 OM (functional/symptomatic) was 51.5% at 2 weeks and 82.9% at 4 weeks after completion of RT. Clinical examination revealed that 10 patients (28.6%) developed grade ≥3 OM. The incidence of grade ≤1 OM (clinical exam) was 80.0% at 2 weeks and 100% at 4 weeks after completion of RT. Only 5.7% of patients had unplanned breaks in radiotherapy, and all patients completed treatment. Adverse events related to HMB/Arg/Gln were increase in blood urea nitrogen and diarrhea, but were easily managed.
Addition of HMB/Arg/Gln to opioid-based pain control and oral care programs was feasible but still insufficient in reducing the incidence of severe CRT-induced oral mucositis. However, the benefit of HMB/Arg/Gln should not be neglected in terms of findings of clinical examination and the recovery from severe oral mucositis.
Clinical trial identification
Legal entity responsible for the study
Public Interest Incorporated Foundation- Shizuoka Industrial Foundation- Pharma Valley Center
All authors have declared no conflicts of interest.