Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Last updated: February 19, 2025
Sponsor: Hunan Cancer Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Heartburn (Pediatric)

Heartburn

Treatment

Oral immunonutrition

Clinical Study ID

NCT06840704
IIT128
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subject voluntarily participates in this clinical study, understands the studyprocedures, and is able to provide written informed consent.

  2. Age ≥ 18 years.

  3. Pathologically confirmed diagnosis of lung cancer, including non-small cell lungcancer 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 (1.5Gy/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% ofthe 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 ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, withcreatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).

  11. Female subjects of childbearing potential, male subjects, and partners of malesubjects agree to use reliable contraceptive methods during the study period (suchas abstinence, sterilization, oral contraceptives, or other contraceptive measures).

Exclusion

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 comorbiditiessuch as liver or kidney diseases.

  8. Female subjects who are pregnant, breastfeeding, or planning to become pregnantduring the study period.

  9. Concurrent active autoimmune diseases requiring treatment.

  10. Known history of human immunodeficiency virus (HIV) positivity or acquiredimmunodeficiency syndrome (AIDS).

  11. Any medical (e.g., pulmonary, metabolic, endocrine, or neurological diseases,congenital disorders, etc.), psychiatric, or social condition that, in theinvestigator's judgment, may interfere with the subject's rights, safety, health, orability to provide informed consent, cooperate and participate in the study, orinterfere with the evaluation of the study drug, interpretation of patient safety,or study results.

Study Design

Total Participants: 121
Treatment Group(s): 1
Primary Treatment: Oral immunonutrition
Phase: 3
Study Start date:
February 25, 2025
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

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