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Clinical Trials in China / NCT06840704
Recruiting Phase 3

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

NCT06840704 · tracked via the Priya Life Science China tracker
Sponsor
Hunan Cancer Hospital
Phase
Phase 3
Started
2025-02-25
Last updated
2026-04-02

Condition(s) studied

Non Small Cell Lung CancerSmall Cell Lung Cancer

Investigational drug(s) / intervention(s)

Oral immunonutrition

Oral immunonutrition: Oral immunonutrition (Oral Impact®, Nestlé), 250 ml per bottle, with a dosage of 2 bottles per day, starting on the day of radiotherapy and continuing for three weeks after radiotherapy.

Study summary

This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent. 2. Age ≥ 18 years. 3. Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer. 4. Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV. 5. Prescription dose for the PTV: 60-70 Gy once daily (2 Gy/Fx), 45 Gy twice daily (1.5 Gy/Fx, with intervals exceeding 6 hours), or 45 Gy once daily (3 Gy/Fx). 6. Ability to orally intake food normally. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 8. The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume. 9. Expected survival of more than 3 months. 10. Laboratory test results during the screening period: Complete blood count: ANC ≥ 1.5 × 10\^9/L; PLT ≥ 80 × 10\^9/L; Hb ≥ 90 g/L. Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula). 11. Female subjects of childbearing potential, male subjects, and partners of male subjects agree to use reliable contraceptive methods during the study period (such as abstinence, sterilization, oral contraceptives, or other contraceptive measures). Exclusion Criteria: 1. Previous history of thoracic radiotherapy. 2. Suspected or confirmed tumor invasion of the esophagus. 3. Patients with other primary tumors. 4. History of esophageal cancer, gastric cancer, or prior esophageal surgery. 5. Concurrent active reflux esophagitis. 6. Current regular use of immunonutrition (e.g., Oral Impact®). 7. Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases. 8. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period. 9. Concurrent active autoimmune diseases requiring treatment. 10. Known history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS). 11. Any medical (e.g., pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric, or social condition that, in the investigator's judgment, may interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate and participate in the study, or interfere with the evaluation of the study drug, interpretation of patient safety, or study results.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Hunan Cancer Hospital Changsha Hunan Recruiting
Third Xiangya Hospital, Central South University Changsha Hunan Recruiting
Xiangya Hospital of Central South University, Changsha Hunan Recruiting
The First People's Hospital of Chenzhou Chenzhou Hunan Recruiting
The Fisrt Affilated Hospital of University of South China Hengyang Hunan Recruiting
Yueyang Central Hospital Yueyang Hunan Recruiting

More Hunan Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06840704 on ClinicalTrials.gov ↗ ← All trials in China