Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer (Relief)

March 28, 2026 updated by: HuaiLiu, Hunan Cancer Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, controlled, open-label clinical trial, which aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute esophagitis after thoracic radiotherapy in lung cancer patients.

Study Type

Interventional

Enrollment (Estimated)

121

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Third Xiangya Hospital, Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University,
        • Contact:
      • Chenzhou, Hunan, China
        • Recruiting
        • The First People's Hospital of Chenzhou
        • Contact:
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The Fisrt Affilated Hospital of University of South China
        • Contact:
      • Yueyang, Hunan, China
        • Recruiting
        • Yueyang Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Standard nutrition
If the patient has concurrent nutritional risks, routine nutritional therapy (no immunonutrition) can be provided under the guidance of a nutritionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of grade 2 or higher acute esophagitis
Time Frame: 3 months
Assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 3 months
3 months
Incidence rate of grade 2 or higher acute esophagitis
Time Frame: 3 months
Assessed according to RTOG toxicity criteria.
3 months
Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria
Time Frame: 3 months
Assessed according to NCI-CTCAE v5.0 criteria
3 months
Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria
Time Frame: 3 months
Assessed according to RTOG toxicity criteria
3 months
Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）
Time Frame: 3 months
PG-SGA scores range from 0 to 35, with higher scores indicating a greater risk of severe malnutrition.
3 months
Nutritional Risk
Time Frame: 3 months
Assessed according to Nutritional Risk Screening 2002 (NRS 2002)
3 months
The duration period of esophagitis
Time Frame: 3 months
The number of days of grade 2 or higher esophagitis
3 months
Opioid use
Time Frame: 3 months
Measured by documented opioid use
3 months
Quality of life assessed by EORTC QLQ-C30
Time Frame: 3 months
EORTC QLQ-C30 scores range from 0 to 100, with higher scores indicating a better quality of life.
3 months
Quality of life assessed by FACT-L
Time Frame: 3 months
FACT-L scores range from 0 to 108, with higher scores indicating a better quality of life.
3 months
Quality of life assessed by FACT-E Eating and Swallowing Subscales
Time Frame: 3 months
FACT-E Eating and Swallowing Subscales scores range from 0 to 68, with higher scores indicating a better quality of life.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Cancer Hospital

Investigators

  • Principal Investigator: Huai Liu, M.D., Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 8, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Hospital policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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