NCT06840704RecruitingPhase 3
Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial
Hunan Cancer Hospital1 site in 1 country121 target enrollmentStarted: February 25, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Hunan Cancer Hospital
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Incidence rate of grade 2 or higher acute esophagitis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •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).
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 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.
Arms & Interventions
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.
Intervention: Oral immunonutrition (Dietary Supplement)
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.
Outcomes
Primary Outcomes
Incidence rate of grade 2 or higher acute esophagitis
Time Frame: 3 months
Assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Secondary Outcomes
- Body weight(3 months)
- Nutritional Risk(3 months)
- The duration period of esophagitis(3 months)
- Opioid use(3 months)
- Incidence rate of grade 2 or higher acute esophagitis(3 months)
- Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria(3 months)
- Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria(3 months)
- Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）(3 months)
- Quality of life assessed by EORTC QLQ-C30(3 months)
- Quality of life assessed by FACT-L(3 months)
- Quality of life assessed by FACT-E Eating and Swallowing Subscales(3 months)
Investigators
HuaiLiu
Prof.
Hunan Cancer Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
The Efficacy of Early Postoperative Enteral Immunonutrition in Low-Risk Cardiac Surgery PatientsCardiac SurgeryNCT04047095Vilnius University55
Completed
Phase 3
Postoperative Enteral Immunonutrition in Gastric CancerGastric CancerNCT02647476Jagiellonian University98
Unknown
Phase 4
Immunonutrition and Thoracoabdominal Aorta Aneurysm RepairThoracic Aortic AneurysmRespiratory InsufficiencyNCT00339053St. Antonius Hospital142
Recruiting
Not Applicable
Management of Esophagitis Following Repair of Esophageal AtresiaEsophageal AtresiaEsophagitisNCT03619408Boston Children's Hospital50
Completed
Phase 4
The Impact of Immunostimulating Nutrition on the Outcome of SurgeryPancreatic CancerGastric CancerNCT00558155Jagiellonian University214