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.
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/㎡).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy
Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
The incidence of weight loss ≥5% during the treatment
The proportion of patients experiencing a weight loss of 5% or more during the CCRT
Time frame: From the start to the end of CCRT
Nutrition-related parameters
Nutrition-related parameters, including weight, body mass index (BMI), hemoglobin (HGB), serum albumin (ALB), pre-albumin (PA), lymphocyte (LY)
Time frame: up to 6 months after radiotherapy
EORTC Quality of Life Questionnaire C30 (QLQ-C30)
Quality of Life
Time frame: up to 6 months after radiotherapy
Scored Patient-Generated Subjective Global Assessment
PG-SGA scores and grades
Time frame: up to 6 months after radiotherapy
Toxicities
Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis.
Time frame: up to 1 year after radiotherapy
Survival outcomes
Including overall survival and progression-free survival.
Time frame: 3 years
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