NCT03673657

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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/㎡).

Conditions

• Local Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Early 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.
RADIATION	Thoracic radiotherapy	Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy
DRUG	Weekly DP chemotherapy concurrent with thoracic radiotherapy	Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy

Timeline

• Start date: 2018-08-10
• Primary completion: 2020-03-16
• Completion: 2023-08-31
• First posted: 2018-09-17
• Last updated: 2023-12-08

Locations

1 site across 1 country: China