Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written willing to sign a consent form. 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: white blood cell count (ANC) at least 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 kidney function (creatinine clearance) at least 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). Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIETARY_SUPPLEMENT

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.

Locations (6)

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