A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The incidence of weight loss ≥5% during the treatment
研究概览
简要总结
This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.
详细描述
This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.
Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. Dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. All patients received definitive thoracic radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed unresectable stage IIIA-IIIC non-small cell lung cancer.
- •Recieved definitive concurrent chemoradiotherapy.
- •Pretreatment PG-SGA score A or B.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Estimated life expectancy of at least 6 months.
- •Without contraindication for chemoradiotherapy.
排除标准
- •Severe impairment of intestinal function, or intolerance of enteral nutrition.
- •Severe vomiting, gastrointestinal bleeding, or intestinal obstruction.
- •Severe malnutrition, or intolerance of chemoradiotherapy.
研究组 & 干预措施
The study group
Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Energy goal: daily total nutritional intake of about 30 kcal/kg.
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
干预措施: Early Nutrition Intervention from the start of CCRT (Dietary Supplement)
The study group
Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Energy goal: daily total nutritional intake of about 30 kcal/kg.
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
干预措施: Thoracic radiotherapy (Radiation)
The study group
Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Energy goal: daily total nutritional intake of about 30 kcal/kg.
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
干预措施: Weekly DP chemotherapy concurrent with thoracic radiotherapy (Drug)
结局指标
主要结局
The incidence of weight loss ≥5% during the treatment
时间窗: From the start to the end of CCRT
The proportion of patients experiencing a weight loss of 5% or more during the CCRT
次要结局
- Scored Patient-Generated Subjective Global Assessment(up to 6 months after radiotherapy)
- Toxicities(up to 1 year after radiotherapy)
- Survival outcomes(3 years)
- Nutrition-related parameters(up to 6 months after radiotherapy)
- EORTC Quality of Life Questionnaire C30 (QLQ-C30)(up to 6 months after radiotherapy)
研究者
Hui Liu
Professor
Sun Yat-sen University