Phase
Condition
Small Cell Lung Cancer
Heartburn (Pediatric)
Heartburn
Treatment
Oral immunonutrition
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject voluntarily participates in this clinical study, understands the studyprocedures, and is able to provide written informed consent.
Age ≥ 18 years.
Pathologically confirmed diagnosis of lung cancer, including non-small cell lungcancer 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 (1.5Gy/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% ofthe 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 ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, withcreatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
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:
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 comorbiditiessuch as liver or kidney diseases.
Female subjects who are pregnant, breastfeeding, or planning to become pregnantduring the study period.
Concurrent active autoimmune diseases requiring treatment.
Known history of human immunodeficiency virus (HIV) positivity or acquiredimmunodeficiency syndrome (AIDS).
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
Study Description
Connect with a study center
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaActive - Recruiting
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