Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Phase 3

Recruiting

• Conditions: Non Small Cell Lung Cancer; Small Cell Lung Cancer

• Registration Number: NCT06840704
• Lead Sponsor: Hunan Cancer Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Study Start: 2025-02-25
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China