Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Incidence of acute radiation reactions
研究概览
简要总结
This study will present an advanced equipment of tumor nutrition diagnosis and assesment for nasopharyngeal cancer(NPC) radiotherapy patients in nutritional risk screening, evaluation, diagnosis and directing nutritional intervention, aiming to explore the advantages of the whole nutritional management in acute radiation reaction rate, completion rate of radiotherapy, nutritional status, and quality of life for NPC patients.
详细描述
In this study, nutrition intervention was performed in one group of nasopharyngeal carcinoma patients with no nutritional risk during the periperiod of radiotherapy , and the other group with no additional intervention when without nutritional risks, for evaluating the value of overall nutritional management in the periperiod radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nasopharyngeal carcinoma confirmed by histopathology
- •Newly diagnosed patients without distant metastasis
- •Nasopharyngeal radiotherapy alone or concurrent chemoradiotherapy was planned to be received, andIMRT was used for radiotherapy
- •The patient's blood counts，the lung, liver and renal functions were tolerant to radiotherapy/chemoradiotherapy（ WBC ≥ 4.0*109/L, NE ≥ 2.0*109/L, PLT 100*109/L and Hb≥ 10g/L. AST and ALT ≤ 2.5 *the upper limit（UL） ,TBIL≤1.2*the UL, CRE≤1.2* the UL, and ALP≤5* the UL）. And the ECG should be normal
- •Good nutritional status,BMI:18~23Kg/ m2, PG-SGA ≤1,NRS 2002<3score
- •No other previous neoplastic diseases, except for cured cervical carcinoma in situ skin basal carcinoma
- •No serious gastrointestinal diseases (moderate and severe duodenal and gastric ulcer, ulcerative colitis, Crohn's disease, etc.)
- •No AIDS and no diabetes
- •Clear mind, no communication barriers, able to answer questions
- •Voluntarily participate and sign the informed consent in person.
排除标准
- •Patients with gastrointestinal dysfunction, intestinal obstruction, pyloric obstruction, Acute gastrointestinal bleeding
- •Patients who are allergic to nutritional therapy or have severe allergic constitution
- •Uncontrolled systemic diseases, such as severe liver disease (such as cirrhosis), kidney disease, respiratory diseases and so on.
- •Women who are pregnant or breastfeeding or no contraception and women with positive pregnancy test before receiving treatment
- •Special dietary requirements: such as no having a certain food or a vegetarian.
研究组 & 干预措施
Intervention group
The recommended target energy for NPC radiotherapy patients is 25-30kcal/(kg·d), in addition，the intervention group begins with an additional 50% daily energy increase during the peri-radiotherapy.
干预措施: Formula nutrition (Dietary Supplement)
Conventional group
Unlike the intervention group,conventional group should be treated according to the consensus of experts on standardized nutrition management.
结局指标
主要结局
Incidence of acute radiation reactions
时间窗: 12 months
This study mainly includes oral mucosa mucositis, salivary glands injury induced by radiotherapy, laryngoesophageal mucositis referring to The 2020 Expert Consensus on the Standardized Management of Radiation Oncology for nutrition-related radiation injury responses.
次要结局
- Incidence of decline in nutritional status(12 months)
- Incidence of decline in quality of life scores（QOL）(12 months)
- Self-rating Anxiety screening Scale（GAD-7)(12 months)
- Self-rating Scale for Depression Screening (PHQ-9)(12 months)
研究者
Yun-fei Xia
Principal Investigator
Sun Yat-sen University