Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

NCT06840704 | Recruiting Phase 3

• 1 other identifier: IIT128
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Non Small Cell Lung Cancer; Small Cell Lung Cancer

Keywords

non-small cell lung cancer; small cell lung cancer; esophagitis; immunonutrition; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Incidence rate of grade 2 or higher acute esophagitis

  3 months

• Incidence rate of grade 3 or higher acute esophagitis 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

  3 months

• Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）

  3 months

• Body weight

  3 months

Study Arms (2)

Oral immunonutrition

EXPERIMENTAL

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

Standard nutrition

NO INTERVENTION

If the patient has concurrent nutritional risks, routine nutritional therapy (no immunonutrition) can be provided under the guidance of a nutritionist.

Interventions

Oral immunonutrition DIETARY_SUPPLEMENT

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.

Oral immunonutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Expected survival of more than 3 months.
• 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).
• 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).

You may not qualify if:

• 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.
• Concurrent active autoimmune diseases requiring treatment.
• Known history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS).
• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (6)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Third Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

RECRUITING

Xiangya Hospital of Central South University,

Changsha, Hunan, China

RECRUITING

The First People's Hospital of Chenzhou

Chenzhou, Hunan, China

RECRUITING

The Fisrt Affilated Hospital of University of South China

Hengyang, Hunan, 421001, China

RECRUITING

Yueyang Central Hospital

Yueyang, Hunan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Esophagitis

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Huai Liu, M.D.

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huai Liu, M.D.

CONTACT

+8673189762230; liuhuai@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 21, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (6)