NCT06840704 Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
| NCT ID | NCT06840704 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hunan Cancer Hospital |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2026-06-30 |
Trial Parameters
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Brief Summary
This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.
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 an
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