Nutrition drink may ease throat pain during lung cancer radiation
NCT ID NCT06840704
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether a daily nutritional drink (Oral Impact®) can reduce severe throat and esophagus inflammation caused by chest radiation in lung cancer patients. About 121 adults with lung cancer who need radiation will drink two bottles a day during and for three weeks after treatment. The study compares how many patients develop serious swallowing pain versus those not receiving the drink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Oral immunonutrition (Oral Impact®)
- What this could lead to
- If it works, this could offer a simple, non-drug way to prevent painful swallowing during lung cancer radiation, improving quality of life.
- What could go wrong
- This is a mid-stage trial with 121 participants, so results may not apply to everyone. The drink may not reduce esophagitis significantly, and some people might not tolerate it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 121 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, 410013, China
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The First People's Hospital of Chenzhou
RECRUITINGChenzhou, Hunan, China
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The Fisrt Affilated Hospital of University of South China
RECRUITINGHengyang, Hunan, 421001, China
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Third Xiangya Hospital, Central South University
RECRUITINGChangsha, Hunan, 410013, China
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Xiangya Hospital of Central South University,
RECRUITINGChangsha, Hunan, China
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Yueyang Central Hospital
RECRUITINGYueyang, Hunan, China
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