Clinical trial · Interventional
Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial
NCT06840704CI-TRIAL-00107173ReliefrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral immunonutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oral immunonutrition
- description
- 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.
- interventionNames
- Dietary Supplement: Oral immunonutrition
- type
- NO_INTERVENTION
- label
- Standard nutrition
- description
- If the patient has concurrent nutritional risks, routine nutritional therapy (no immunonutrition) can be provided under the guidance of a nutritionist.
Primary outcomes (1)
- measure
- Incidence rate of grade 2 or higher acute esophagitis
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.