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

Phase 2

Completed

• Conditions: Local Advanced Non-small Cell Lung Cancer
• Interventions: Dietary Supplement: Early Nutrition Intervention from the start of CCRT; Radiation: Thoracic radiotherapy; Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy

• Registration Number: NCT03673657
• Lead Sponsor: Sun Yat-sen University

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/㎡).

Study Timeline

• Study Start: 2018-08-10
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Primary Completion: 2020-03-16
• Study Completion: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study group	Early Nutrition Intervention from the start of CCRT	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.
The study group	Thoracic radiotherapy	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.
The study group	Weekly DP chemotherapy concurrent with thoracic radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Scored Patient-Generated Subjective Global Assessment	up to 6 months after radiotherapy	PG-SGA scores and grades
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.
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

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China