Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy
Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy
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DOI：
10.1016/j.radonc.2017.10.015
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发表时间：
2018-01-01
影响因子：
5.7
通讯作者：
Caccialanza, Riccardo
中科院分区：
文献类型：
--
作者：
Cereda, Emanuele;Cappello, Silvia;Caccialanza, Riccardo
背景：为了评估接受放射治疗（RT）的头颈癌（HNC）患者除了营养咨询之外口服营养补充剂（ONS）的益处。方法：在一项单中心、随机、务实、平行组对照试验（ClinicalTrials.gov：NCT02055833；2014年2月-2016年8月）中，159名新诊断的适合接受放射治疗的HNC患者，无论既往手术和诱导化疗情况如何。从 RT 开始到结束后持续 3 个月，被随机分配到联合 ONS 的营养咨询组 (N = 78) 或不联合 ONS 的营养咨询组 (N = 81)。 方法：主要终点是 RT 结束时的体重变化。次要终点包括蛋白质热量摄入量、肌肉力量、相位角和生活质量以及抗癌治疗耐受性的变化。 结果：在评估主要终点的患者（改良意向治疗人群）中，咨询加 ONS (N = 67) 导致的体重损失比单独营养咨询更小 (N = 69；平均差，1.6 kg [95%Cl, 0.5-2.7]；P = 0.006)。对缺失结果的估算提供了一致的发现。在补充 ONS 的组中，随着时间的推移，还观察到更高的蛋白质热量摄入和生活质量的改善（全部 P < 0.001）。 ONS 的使用减少了改变预定抗癌治疗的需要（即放疗和/或全身治疗剂量减少或完全暂停，HR=0.40 [95%Cl，0.18-0.91]，P = 0.029）。结论：在接受放疗或放疗加全身治疗并接受营养咨询的 HNC 患者中，使用 ONS 可以更好地维持体重，增加蛋白质热量摄入，改善生活质量，并与更好的抗癌治疗耐受性。 (C) 2017 Elsevier B.V. 保留所有权利。
Background: To evaluate the benefit of oral nutritional supplements (ONS) in addition to nutritional counseling in head and neck cancer (HNC) patients undergoing radiotherapy (RT).Methods: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02055833; February 2014-August 2016), 159 newly diagnosed HNC patients suitable for to RT regardless of previous surgery and induction chemotherapy were randomly assigned to nutritional counseling in combination with ONS (N = 78) or without ONS (N = 81) from the start of RT and continuing for up to 3 months after its end.Methods: Primary endpoint was the change in body weight at the end of RT. Secondary endpoints included changes in protein-calorie intake, muscle strength, phase angle and quality of life and anticancer treatment tolerance.Results: In patients with the primary endpoint assessed (modified intention-to-treat population), counseling plus ONS (N = 67) resulted in smaller loss of body weight than nutritional counseling alone (N = 69; mean difference, 1.6 kg [95%Cl, 0.5-2.7]; P = 0.006). Imputation of missing outcomes provided consistent findings. In the ONS-supplemented group, higher protein-calorie intake and improvement in quality of life over time were also observed (P < 0.001 for all). The use of ONS reduced the need for changes in scheduled anti-cancer treatments (i.e. for RT and/or systemic treatment dose reduction or complete suspension, HR=0.40 [95%Cl, 0.18-0.91], P = 0.029).Conclusion: In HNC patients undergoing RT or RT plus systemic treatment, and receiving nutritional counseling, the use of ONS resulted in better weight maintenance, increased protein-calorie intake, improved quality of life and was associated with better anti-cancer treatment tolerance. (C) 2017 Elsevier B.V. All rights reserved.