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

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: Small Cell Lung Cancer; Non Small Cell Lung Cancer
• Intervention / Treatment: Dietary supplement: Oral immunonutrition

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

• Study Contact: Name: Huai Liu, M.D.; Phone Number: +8673189762230; Email: liuhuai@hnca.org.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Huai Liu, M.D.; Phone Number: +8673189762230; Email: liuhuai@hnca.org.cn
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Third Xiangya Hospital, Central South University
      • Contact: Xuewen Liu; Phone Number: +8618711033808; Email: aveinliu@163.com
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University,
      • Contact: Rongrong Zhou; Phone Number: +8613875898127; Email: zhourr@csu.edu.cn
    • Chenzhou, Hunan, China
      • Recruiting
      • The First People's Hospital of Chenzhou
      • Contact: Qiyuan Zhou; Phone Number: 8618175547107; Email: czyyflgcp@163.com
    • Hengyang, Hunan, China, 421001
      • Recruiting
      • The Fisrt Affilated Hospital of University of South China
      • Contact: Yuehua Li; Phone Number: +8618216037899; Email: liyuehua2020@stu.usc.edu.cn
    • Yueyang, Hunan, China
      • Recruiting
      • Yueyang Central Hospital
      • Contact: Jie Weng; Phone Number: 8613975070672; Email: 3173720582@qq.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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		3 months
Incidence rate of grade 2 or higher acute esophagitis	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	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	Assessed according to RTOG toxicity criteria	3 months
Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）	PG-SGA scores range from 0 to 35, with higher scores indicating a greater risk of severe malnutrition.	3 months
Nutritional Risk	Assessed according to Nutritional Risk Screening 2002 (NRS 2002)	3 months
The duration period of esophagitis	The number of days of grade 2 or higher esophagitis	3 months
Opioid use	Measured by documented opioid use	3 months
Quality of life assessed by EORTC QLQ-C30	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	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	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

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

Study record dates

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: non-small cell lung cancer; radiotherapy; immunonutrition; small cell lung cancer; esophagitis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Esophageal Diseases; Lung Neoplasms; Gastroenteritis; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Esophagitis; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet; Immunonutrition Diet
• 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