*Department of Head and Neck Surgery, Miyagi Cancer Center, Natori, Miyagi 981-1293, Japan.
Jpn J Clin Oncol. 2014 May;44(5):422-7. doi: 10.1093/jjco/hyu027. Epub 2014 Mar 30.
This prospective randomized Phase II study was designed to evaluate the preventive effect of an oral nutrition supplement composed of beta-hydroxy-beta-methylbutyrate, arginine and glutamine (beta-hydroxy-beta-methylbutyrate/arginine/glutamine) on radiation dermatitis in head and neck cancer patients.
Forty patients with histologically proven head and neck cancer, treated with concurrent chemoradiotherapy involving cisplatin were recruited. They were randomly assigned to the beta-hydroxy-beta-methylbutyrate/arginine/glutamine supplement treatment group (Group A) or the control group that received no supplement (Group B). The primary endpoint of this study was the percentage of patients developing ≥Grade 3 dermatitis. The secondary endpoints were the percentage of patients developing ≥Grade 2 dermatitis, and the duration of each grade of dermatitis relative to the observation period.
The incidence of ≥Grade 3 dermatitis did not differ between the two groups. However, as secondary endpoints of this study, the incidence of ≥Grade 2 dermatitis was lower in Group A than B (62.6 vs. 94.4%; P < 0.05), and the duration of ≥Grade 1 dermatitis was shorter in Group A than B (44.8 vs. 56.7%; P < 0.01), as was the duration of ≥Grade 2 dermatitis (16.5 vs. 26.5%; P < 0.05).
Our study indicated that beta-hydroxy-beta-methylbutyrate/arginine/glutamine supplementation was potentially effective in the prevention of radiation dermatitis in head and neck cancer patients.
本前瞻性随机二期研究旨在评估由β-羟基-β-甲基丁酸、精氨酸和谷氨酰胺组成的口服营养补充剂对接受顺铂同期放化疗的头颈部癌症患者放射性皮炎的预防作用。
共招募了 40 名经组织学证实的头颈部癌症患者，他们接受了包含顺铂的同期放化疗。他们被随机分配到β-羟基-β-甲基丁酸/精氨酸/谷氨酰胺补充治疗组（A 组）或未接受补充剂的对照组（B 组）。本研究的主要终点是发生≥3 级皮炎的患者比例。次要终点是发生≥2 级皮炎的患者比例，以及每个级别的皮炎相对于观察期的持续时间。
两组患者≥3 级皮炎的发生率无差异。然而，作为本研究的次要终点，A 组发生≥2 级皮炎的比例低于 B 组（62.6%比 94.4%；P<0.05），A 组≥1 级皮炎的持续时间短于 B 组（44.8 比 56.7%；P<0.01），A 组≥2 级皮炎的持续时间也短于 B 组（16.5 比 26.5%；P<0.05）。
我们的研究表明，β-羟基-β-甲基丁酸/精氨酸/谷氨酰胺补充剂可能对头颈部癌症患者放射性皮炎的预防有效。
