Tomoya Yokota1, Satoshi Hamauchi2, Yukio Yoshida2, Takashi Yurikusa3, Miho Suzuki3, Aiko Yamashita4, Hirofumi Ogawa5, Tsuyoshi Onoe5, Keita Mori6, Tetsuro Onitsuka7. 1. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. t.yokota@scchr.jp. 2. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. 3. Division of Dental and Oral Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. 4. Division of Nutrition, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. 5. Division of Radiation Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. 6. Clinical Trial Coordination Office, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. 7. Division of Head and Neck Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Abstract
PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: UMIN000016453.
PURPOSE: 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). METHODS: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. RESULTS: 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 ureanitrogen and diarrhea, but were easily managed. CONCLUSIONS: 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. TRIAL REGISTRATION: UMIN000016453.
Entities:
Keywords:
Chemoradiotherapy; HMB/Arg/Gln; Head and neck cancer; Oral care; Oral mucositis
Authors: JoAnne Whitney; Linda Phillips; Rummana Aslam; Adrian Barbul; Finn Gottrup; Lisa Gould; Martin C Robson; George Rodeheaver; David Thomas; Nancy Stotts Journal: Wound Repair Regen Date: 2006 Nov-Dec Impact factor: 3.617
Authors: Jennifer A Kushner; Herenia P Lawrence; Irit Shoval; Thomas L Kiss; Gerald M Devins; Linda Lee; Howard C Tenenbaum Journal: J Can Dent Assoc Date: 2008-02 Impact factor: 1.316
Authors: Agostino Paccagnella; Michela Morello; Maria C Da Mosto; Carla Baruffi; Maria L Marcon; Alessandro Gava; Vittorio Baggio; Stefano Lamon; Roberta Babare; Giovanni Rosti; Marta Giometto; Paolo Boscolo-Rizzo; Edward Kiwanuka; Michele Tessarin; Lorenza Caregaro; Carlo Marchiori Journal: Support Care Cancer Date: 2009-08-30 Impact factor: 3.603
Authors: Carla M Prado; Camila E Orsso; Suzette L Pereira; Philip J Atherton; Nicolaas E P Deutz Journal: J Cachexia Sarcopenia Muscle Date: 2022-03-17 Impact factor: 12.063