A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Early Nutrition Intervention from the start of CCRT
- Conditions
- Local Advanced Non-small Cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- The incidence of weight loss ≥5% during the treatment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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/㎡).
Investigators
Hui Liu
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Severe impairment of intestinal function, or intolerance of enteral nutrition.
- •Severe vomiting, gastrointestinal bleeding, or intestinal obstruction.
- •Severe malnutrition, or intolerance of chemoradiotherapy.
Arms & Interventions
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.
Intervention: Early Nutrition Intervention from the start of CCRT
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.
Intervention: Thoracic radiotherapy
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.
Intervention: Weekly DP chemotherapy concurrent with thoracic radiotherapy
Outcomes
Primary Outcomes
The incidence of weight loss ≥5% during the treatment
Time Frame: From the start to the end of CCRT
The proportion of patients experiencing a weight loss of 5% or more during the CCRT
Secondary Outcomes
- 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)