A Randomized Controlled Trial of an Early Oral Nutritional Supplements Intervention Versus a Conventional Nutritional Intervention in Patients With Locally Advanced Nasopharyngeal Carcinoma Undergoing Concurrent Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- The percentage of patients who lose >5% of initial body weight
研究概览
简要总结
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.
详细描述
Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy.
Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy.
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed nasopharyngeal carcinoma (NPC).
- •The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition).
- •Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT).
- •Age ≥ 18 years and < 75 years.
- •Performance status (PS) score 0-
- •NRS2002<3 .
- •Blood regular test should be satisfied the following conditions: white blood cell count ≥3.5×109/L， Neutrophil count ≥1.5×109/L，platelet count ≥100×109/L，hemoglobin ≥10g/L
- •Liver and kidney functions test should be satisfied the following conditions: aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value, bilirubin < 1.2 times the upper limit of normal value, creatinine < 1.2 times the upper limit of normal value, and alkaline phosphatase < 5 times the upper limit of normal value.
- •Could complete required oral nutrition, questionnaire survey and follow-up.
- •Signed informed consent voluntarily.
排除标准
- •Had a history of head and neck radiotherapy.
- •Known allergic reaction to any component of ONS, or severe allergic constitution.
- •With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on).
- •Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction).
- •Pregnancy and lactation.
- •Other conditions that the investigators consider as inappropriate for enrolling into this study.
- •Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.
结局指标
主要结局
The percentage of patients who lose >5% of initial body weight
时间窗: 7 weeks
Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy \*100 %.
次要结局
- Patient-generated Subjective Global Assessment (PG-SGA) at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy(11 weeks)
- The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation(5 months)
- The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation(5 months)
- Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy(7 weeks)
- Weight loss at the last day of radiotherapy(7 weeks)
- Weight loss at the end of 4th week(11 weeks)
- Incidence of any grade 3-4 side-effect (CTCAE 4.03).(7 weeks)
- Days prolonged more than planed treatment time caused by side-effects(7 weeks)
- Incidence of unplanned hospitalization in 3 months after radiation(5 months)
- The treatment time of parenteral nutrition (PN) treatment(5 months)
- Incidence of prolonged radiation treatment time caused by side-effects(7 weeks)
研究者
YI PAN
Prof.
Guangdong Provincial People's Hospital