Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Launched by HUNAN CANCER HOSPITAL · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called immunonutrition to see if it can help reduce a painful condition called acute esophagitis, which can occur after radiation therapy for lung cancer. The trial is specifically looking at patients with non-small cell lung cancer or small cell lung cancer who are about to receive radiation therapy to the chest area. To be eligible for the study, participants need to be at least 18 years old, have a confirmed diagnosis of lung cancer, and be able to eat food normally. They also should not have certain health issues, like previous radiation treatment to the chest or other serious medical conditions.

If you join this trial, you'll receive either the immunonutrition treatment or standard care while your doctors monitor your health and any side effects. The study is actively recruiting participants of all genders, and it aims to help improve the comfort and care of patients undergoing radiation therapy for lung cancer. Your participation could contribute valuable information to help future patients.

Gender

ALL

Eligibility criteria

• 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.