Local Advanced Non-small Cell Lung Cancer
Conditions
Keywords
Local Advanced Non-small Cell Lung Cancer, Chemoradiotherapy, Early nutritional intervention
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/㎡).
Interventions
DIETARY_SUPPLEMENTEarly Nutrition Intervention from the start of CCRT
Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.
RADIATIONThoracic radiotherapy
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy
DRUGWeekly DP chemotherapy concurrent with thoracic radiotherapy
Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 0-1. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of weight loss ≥5% during the treatment | From the start to the end of CCRT | The proportion of patients experiencing a weight loss of 5% or more during the CCRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition-related parameters | up to 6 months after radiotherapy | Nutrition-related parameters, including weight, body mass index (BMI), hemoglobin (HGB), serum albumin (ALB), pre-albumin (PA), lymphocyte (LY) |
| EORTC Quality of Life Questionnaire C30 (QLQ-C30) | up to 6 months after radiotherapy | Quality of Life |
| Toxicities | up to 1 year after radiotherapy | Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis. |
| Survival outcomes | 3 years | Including overall survival and progression-free survival. |
| Scored Patient-Generated Subjective Global Assessment | up to 6 months after radiotherapy | PG-SGA scores and grades |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory endpoint | From the start to the end of CCRT | The association between oral nutritional supplements outcome and the gut microbiota. |
Countries
China
Outcome results
None listed