Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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/㎡).

Official Title
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A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

Conditions
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Local Advanced Non-small Cell Lung Cancer

Intervention / Treatment
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* Dietary Supplement: Early Nutrition Intervention from the start of CCRT
* Radiation: Thoracic radiotherapy
* Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study group<br>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. | Dietary Supplement: Early Nutrition Intervention from the start of CCRT<br>* Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.<br>Radiation: Thoracic radiotherapy<br>* Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy<br>Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy<br>* Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of weight loss ≥5% during the treatment | The proportion of patients experiencing a weight loss of 5% or more during the CCRT | From the start to the end of CCRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition-related parameters | Nutrition-related parameters, including weight, body mass index (BMI), hemoglobin (HGB), serum albumin (ALB), pre-albumin (PA), lymphocyte (LY) | up to 6 months after radiotherapy | 
| EORTC Quality of Life Questionnaire C30 (QLQ-C30) | Quality of Life | up to 6 months after radiotherapy | 
| Scored Patient-Generated Subjective Global Assessment | PG-SGA scores and grades | up to 6 months after radiotherapy | 
| Toxicities | Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis. | up to 1 year after radiotherapy | 
| Survival outcomes | Including overall survival and progression-free survival. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local Advanced Non-small Cell Lung Cancer, Chemoradiotherapy, Early nutritional intervention