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New treatment option for Non Small Cell Lung Cancer
Official title Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
ClinicalTrials.gov ID: NCT06840704
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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®).
See the full eligibility 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...
- Female people of childbearing potential, male people, and partners of male people agree to use reliable contraceptive methods during the study period (such as abstinence, sterilization, oral contraceptives, or other...
- 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 people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Chenzhou, Hunan, China
- Hengyang, Hunan, China
- Yueyang, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Chenzhou, Hunan, China; Hengyang, Hunan, China; Yueyang, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.