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- Title
A phase II study of HMB/Arg/Gln against oral mucositis induced by chemoradiotherapy for patients with head and neck cancer.
- Authors
Yokota, Tomoya; Hamauchi, Satoshi; Yoshida, Yukio; Yurikusa, Takashi; Suzuki, Miho; Yamashita, Aiko; Ogawa, Hirofumi; Onoe, Tsuyoshi; Mori, Keita; Onitsuka, Tetsuro
- Abstract
<bold>Purpose: </bold>This phase II trial assessed the clinical benefit of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine (HMB/Arg/Gln) for preventing chemoradiotherapy (CRT)-induced oral mucositis (OM) in patients with head and neck cancer (HNC).<bold>Methods: </bold>Patients with HNC receiving 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 its completion. All patients received opioid-based pain control and oral care programs that we previously reported. The primary endpoint was the incidence of grade ≥ 3 OM (functional/symptomatic) according to the Common Terminology Criteria of Adverse Events version 3.0. Quality of life (EORTC QLQ-C30/PROMS) at baseline and upon radiotherapy at a dosage of 50 Gy were assessed.<bold>Results: </bold>Thirty-five patients with HNC were enrolled. Sixteen of them (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 radiotherapy completion. 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 radiotherapy completion. Adverse events related to HMB/Arg/Gln were an increase in blood urea nitrogen and diarrhea, but were easily managed.<bold>Conclusions: </bold>The addition of HMB/Arg/Gln to opioid-based pain control and oral care programs was feasible but still insufficient at reducing the incidence of CRT-induced severe OM. However, the benefit of HMB/Arg/Gln should not be neglected given the findings of clinical examinations and the rapid recovery from severe OM.<bold>Trial Registration: </bold>UMIN000016453.
- Subjects
MUCOSITIS; BETA-hydroxy-beta-methylbutyrate; ARGININE; GLUTAMINE; HEAD &; neck cancer patients; CHEMORADIOTHERAPY; THERAPEUTICS; MENTAL health; QUALITY of life; CLINICAL trials; HEAD tumors; NECK tumors; OLIGOPEPTIDES; QUESTIONNAIRES; STOMATITIS; DISEASE complications; SHORT-chain fatty acids
- Publication
Supportive Care in Cancer, 2018, Vol 26, Issue 9, p3241
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-018-4175-4