Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06840704

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Led by Hunan Cancer Hospital · Updated on 2026-04-02

121

Participants Needed

6

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation with informed consent
  • Age 18 years or older
  • Pathologically confirmed non-small cell or small cell lung cancer
  • Indication for thoracic radiotherapy with esophagus within 1 cm of the planned treatment volume
  • Prescription radiation dose of 60-70 Gy once daily, 45 Gy twice daily with intervals over 6 hours, or 45 Gy once daily
  • Ability to take food orally in a normal way
  • ECOG performance status score of 0-1
  • Lung volume receiving more than 20 Gy radiation does not exceed 30% of total lung volume
  • Expected survival longer than 3 months
  • Laboratory tests within specified limits: ANC ≥ 1.5 × 10^9/L; platelets ≥ 80 × 10^9/L; hemoglobin ≥ 90 g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN; BUN and creatinine ≤ 1.5 × ULN; creatinine clearance ≥ 50 mL/min
  • Agreement to use reliable contraception during study for women of childbearing potential, men, and partners of men
Not Eligible

You will not qualify if you...

  • Prior thoracic radiotherapy
  • Suspected or confirmed tumor invasion of the esophagus
  • Presence of other primary tumors
  • History of esophageal or gastric cancer, or prior esophageal surgery
  • Active reflux esophagitis
  • Current regular use of immunonutrition supplements like Oral Impact®
  • Severe cardiovascular, cerebrovascular, liver, or kidney diseases
  • Women who are pregnant, breastfeeding, or planning pregnancy during the study
  • Active autoimmune diseases requiring treatment
  • Positive for HIV or AIDS
  • Any medical, psychiatric, or social condition that may affect safety, consent, cooperation, or study evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

2

Third Xiangya Hospital, Central South University

Changsha, Hunan, China, 410013

Actively Recruiting

3

Xiangya Hospital of Central South University,

Changsha, Hunan, China

Actively Recruiting

4

The First People's Hospital of Chenzhou

Chenzhou, Hunan, China

Actively Recruiting

5

The Fisrt Affilated Hospital of University of South China

Hengyang, Hunan, China, 421001

Actively Recruiting

6

Yueyang Central Hospital

Yueyang, Hunan, China

Actively Recruiting

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Research Team

H

Huai Liu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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