Recruiting NCT06840704
Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral immunonutrition.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer, Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial
Overview
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.
Interventions
- Dietary supplement Oral immunonutrition
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.
Primary outcome measures
- Incidence rate of grade 2 or higher acute esophagitis [Time frame: 3 months]
Secondary outcome measures (11)
- Incidence rate of grade 2 or higher acute esophagitis [Time frame: 3 months]
- Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria [Time frame: 3 months]
- Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria [Time frame: 3 months]
- Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA） [Time frame: 3 months]
- Body weight [Time frame: 3 months]
- Nutritional Risk [Time frame: 3 months]
- The duration period of esophagitis [Time frame: 3 months]
- Opioid use [Time frame: 3 months]
- Quality of life assessed by EORTC QLQ-C30 [Time frame: 3 months]
- Quality of life assessed by FACT-L [Time frame: 3 months]
- Quality of life assessed by FACT-E Eating and Swallowing Subscales [Time frame: 3 months]
Eligibility criteria
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 0-1.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 6 centers
- Hunan Cancer Hospital — Changsha
- Third Xiangya Hospital, Central South University — Changsha
- Xiangya Hospital of Central South University, — Changsha
- The First People's Hospital of Chenzhou — Chenzhou
- The Fisrt Affilated Hospital of University of South China — Hengyang
- Yueyang Central Hospital — Yueyang
Identifiers
NCT: NCT06840704 · IIT128