Using immunonutrition to reduce esophagitis in lung cancer patients undergoing radiotherapy
Official title: Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial
Run by Hunan Cancer Hospital · NCT06840704 · Data updated 2026-11-12
This study is testing if a special nutritional drink can help lung cancer patients undergoing radiation therapy experience less throat irritation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 121 (estimated) |
| Sponsor | Hunan Cancer Hospital Academic / other |
| Locations | 6 sites (Changsha, Hunan and 5 other locations) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT06840704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a confirmed diagnosis of lung cancer who are scheduled for thoracic radiotherapy.
✕Probably not a fit
Patients who are unable to orally intake food normally or have a poor performance status may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of oral immunonutrition therapy in minimizing acute esophagitis in patients with lung cancer receiving thoracic radiotherapy. It is a prospective, randomized, controlled, open-label study that aims to determine both the efficacy and safety of this nutritional intervention. Participants will be monitored for changes in esophagitis symptoms following their radiotherapy treatment. The study focuses on patients diagnosed with either non-small cell or small cell lung cancer who are scheduled for specific radiation doses.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence and severity of esophagitis in lung cancer patients undergoing radiotherapy, improving their quality of life.
How similar studies have gone: While there have been studies exploring nutritional interventions in cancer care, the specific use of immunonutrition to address esophagitis in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hunan Cancer Hospital
Changsha, Hunan, China Recruiting -
Third Xiangya Hospital, Central South University
Changsha, Hunan, China Recruiting -
Xiangya Hospital of Central South University,
Changsha, Hunan, China Recruiting -
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China Recruiting -
The Fisrt Affilated Hospital of University of South China
Hengyang, Hunan, China Recruiting -
Yueyang Central Hospital
Yueyang, Hunan, China Recruiting
Study contacts
- Principal investigator: Huai Liu, M.D. — Hunan Cancer Hospital
- Study coordinator: Huai Liu, M.D.
- Email: liuhuai@hnca.org.cn
- Phone: +8673189762230
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.