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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Local Advanced Non-small Cell Lung Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03673657

GASTO-1041

Details and patient eligibility

About

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.

Full 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/㎡).

Enrollment: 67 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

The study group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Early Nutrition Intervention from the start of CCRT

Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy

Radiation: Thoracic radiotherapy