Clinical trial NCT06840704: Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
Official title: Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Small Cell Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
esophagitis
immunonutrition
radiotherapy
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence rate of grade 2 or higher acute esophagitis
timeFrame: 3 months
Secondary outcomes:
measure: Incidence rate of grade 2 or higher acute esophagitis
timeFrame: 3 months
measure: Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria
timeFrame: 3 months
measure: Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria
timeFrame: 3 months
measure: Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）
timeFrame: 3 months
measure: Body weight
timeFrame: 3 months
measure: Nutritional Risk
timeFrame: 3 months
measure: The duration period of esophagitis
timeFrame: 3 months
measure: Opioid use
timeFrame: 3 months
measure: Quality of life assessed by EORTC QLQ-C30
timeFrame: 3 months
measure: Quality of life assessed by FACT-L
timeFrame: 3 months
measure: Quality of life assessed by FACT-E Eating and Swallowing Subscales
timeFrame: 3 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Huai Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: