A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Body weight(kg)change during concurrent chemotherapy
研究概览
简要总结
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
- •Concurrent radiation and chemotherapy(platinum )
- •Karnofsky score over 60
- •No evidence of metastatic disease
- •No significant cardiac, chest, gastrointestinal or renal morbidities
排除标准
- •age <18 years
- •ongoing artificial nutrition
研究组 & 干预措施
ONS group
Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)
干预措施: Healing Elements,Methuselah Medical Technology (Dietary Supplement)
control group
Individualized dietary counseling during CRT
结局指标
主要结局
Body weight(kg)change during concurrent chemotherapy
时间窗: every week during the course of radiotherapy, up to 6-7 weeks
次要结局
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment(every 2 weeks during the course of radiotherapy, up to 6-7 weeks)
- Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis(every week during the course of radiotherapy, up to 6-7 weeks)
- Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis(every week during the course of radiotherapy, up to 6-7 weeks)
- Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis(every week during the course of radiotherapy, up to 6-7 weeks)
- Disease-free survival(2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0(every week during the course of radiotherapy, up to 6-7 weeks)
- Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis(every week during the course of radiotherapy, up to 6-7 weeks)
- Serum prealbumin（mg/dL) change(every 2 weeks during the course of radiotherapy, up to 6-7 weeks)
- Serum transferrins（mg/dL）change(every 2 weeks during the course of radiotherapy, up to 6-7 weeks)
- Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis(every week during the course of radiotherapy, up to 6-7 weeks)
- Serum albumin（g/L) change(every 2 weeks during the course of radiotherapy, up to 6-7 weeks)
研究者
Guopei Zhu
Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University