A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).
详细描述
This clinical trial will be conducted in a single-center, prospective, and randomized manner. In this protocol, the standard radio(chemo)therapy duration is 6-7 weeks. Early enteral nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before post-operative radio(chemo)therapy begins and stopping this intervention when post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional supplementation was given either through the oral route (Cohort 1) or tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). Dietitians will design meal plans for both groups of subjects so that their normal diets will provide 25-30 kcal/d/kg body weight in addition to nutritional supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Subject is male or female, between 18 and 70 years old;
- •Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment;
- •Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months;
- •Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol;
- •Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study
排除标准
- •Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician.
- •Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician.
- •Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician;
- •Subject has diabetes
- •Subject has known history of allergy or intolerance to any ingredient in the investigational product;
- •Female subjects are pregnant or plan to get pregnant within a year or are postpartum and non-lactating;
- •Subject has mental illness, cannot understand ICF, unwilling to provide informed consent.
- •Subject has amputation or implanted electronic devices or metal, it may be inappropriate to use BIA to measure body composition
- •Subject is currently or has participated in any clinical trial 2 months prior to enrollment.
- •Subject plans to take nutritional supplements and/or traditional Chinese medicine regularly during study in the opinion of study physician. Multi-vitamin and multi-mineral supplements are exception.
结局指标
主要结局
Body weight
时间窗: 10 weeks
changes of body weight from baseline to Final Visit/Exit.
次要结局
- Quality of life assessed by Quality of Life Questionnaire-Head and Neck 35 questionnaire of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-H&N35(5 weeks, 8 weeks, 10 weeks)
- Health economics assessment on medications treatment due to complications(10 weeks)
- Radio(chemo)therapy treatment effect(10 weeks)
- Body weight(2weeks,5 weeks, 8 weeks)
- Hemoglobin by drawing blood(5weeks 10 weeks)
- White blood cell by drawing blood(5weeks 10 weeks)
- Tolerability to radio(chemo)therapy assessment on complications(5 weeks, 8 weeks, 10 weeks)
- Body Mass Index(10 weeks)
- Calf circumference by measure(5weeks, 10 weeks)
- Lean mass measured by Bioelectrical impedance analysis (BIA)(5weeks 10 weeks)
- Patient-Generated Subjective Global Assessment/PG-SGA scores(5weeks 10 weeks)
- Dietary adherence and intake assessment(2weeks,5 weeks, 8 weeks, 10 weeks)
- Prealbumin by drawing blood(5weeks 10 weeks)
- Fat mass measured by Bioelectrical impedance analysis (BIA)(5weeks 10 weeks)
- Albumin by drawing blood(5weeks 10 weeks)
- Peripheral blood lymphocyte by drawing blood(5weeks 10 weeks)
- Tolerability to radio(chemo)therapy assessment on treatment status(5 weeks, 8 weeks, 10 weeks)
- Tolerability to radio(chemo)therapy assessment on treatment change due to side effects(5 weeks, 8 weeks, 10 weeks)
- Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications(5 weeks, 8 weeks, 10 weeks)
- Quality of life assessed by Quality of Life Questionnaire-Core 36 of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-C30 questionnaire(5 weeks, 8 weeks, 10 weeks)
研究者
Guopei Zhu
Director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University