RecruitingPhase 3

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

China121 participantsStarted 2025-02-25

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent.
✓. Age ≥ 18 years.
✓. Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer.
✓. Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV.
✓. 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).
✓. Ability to orally intake food normally.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
✓. The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume.

✕. Previous history of thoracic radiotherapy.
✕. Suspected or confirmed tumor invasion of the esophagus.
✕. Patients with other primary tumors.
✕. History of esophageal cancer, gastric cancer, or prior esophageal surgery.
✕. Concurrent active reflux esophagitis.
✕. Current regular use of immunonutrition (e.g., Oral Impact®).
✕. Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases.
✕. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.

Incidence rate of grade 2 or higher acute esophagitis

Timeframe: 3 months

NCT IDNCT06840704

SponsorHunan Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Huai Liu, M.D.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent.
✓. Age ≥ 18 years.
✓. Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer.
✓. Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV.
✓. 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).
✓. Ability to orally intake food normally.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
✓. The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume.

✕. Previous history of thoracic radiotherapy.
✕. Suspected or confirmed tumor invasion of the esophagus.
✕. Patients with other primary tumors.
✕. History of esophageal cancer, gastric cancer, or prior esophageal surgery.
✕. Concurrent active reflux esophagitis.
✕. Current regular use of immunonutrition (e.g., Oral Impact®).
✕. Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases.
✕. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.