Tests nutrition supplement to reduce throat irritation from chest radiotherapy in lung cancer
Tests an immune-support nutrition drink in adults with lung cancer receiving chest radiation.
Key facts
- Who runs it
- Hunan Cancer Hospital
- Where
- Changsha, Chenzhou, Hengyang, and Yueyang, ChinaSee the 6 sites
- Trial code
- Registry title
- Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 121 people, planned
- Started
- 25 Feb 2025
- Expected to end
- 30 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Oral immunonutrition
- Record updated
- 2 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer who will have chest radiotherapy. It tests whether an immunonutrition supplement lowers acute esophagitis (a sore, inflamed food pipe) after radiotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Lung cancer confirmed by tissue tests, non-small cell or small cell. Chest radiotherapy planned, with the esophagus within 1 cm (0.4 in) of the target area. Expected survival of more than 3 months.
- Earlier treatment
- No earlier chest radiotherapy. No regular use of immunonutrition such as Oral Impact®.
Main reasons for not taking part
- Earlier chest radiotherapy
- Suspected or confirmed tumor invasion of the esophagus, or past esophageal cancer, stomach cancer or esophageal surgery
- Active reflux esophagitis
- Another primary tumor, or active autoimmune disease needing treatment
- Pregnancy or breastfeeding, or known HIV positivity or AIDS
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Previous history of thoracic radiotherapy
- History of esophageal cancer, gastric cancer, or prior esophageal surgery
- Concurrent active reflux esophagitis
- Concurrent active autoimmune diseases requiring treatment
- Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases
- 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
- Suspected or confirmed tumor invasion of the esophagus
- Patients with other primary tumors
- Current regular use of immunonutrition (e.g., Oral Impact®)
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period
Where in China
- Hunan Cancer HospitalChangsha, ChinaContact: Huai Liu, M.D.Taking people
- Third Xiangya Hospital, Central South UniversityChangsha, ChinaContact: Xuewen LiuTaking people
- Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Rongrong ZhouTaking people
- The First People's Hospital of ChenzhouChenzhou, ChinaContact: Qiyuan ZhouTaking people
- The Fisrt Affilated Hospital of University of South ChinaHengyang, ChinaContact: Yuehua LiTaking people
- Yueyang Central HospitalYueyang, ChinaContact: Jie WengTaking people
About the trial
What the trial wants to find out
This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.
The 2 groups in the trial
- Oral immunonutritionTreatment being tested
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.
- Standard nutritionNo study treatment, for comparison
If the patient has concurrent nutritional risks, routine nutritional therapy (no immunonutrition) can be provided under the guidance of a nutritionist.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial
- Plain-language title
- Tests nutrition supplement to reduce throat irritation from chest radiotherapy in lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 April 2026