Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial

Plain English Summary

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer is a Phase 3 clinical trial sponsored by Hunan Cancer Hospital studying Non Small Cell Lung Cancer, Small Cell Lung Cancer. This trial tests if a special drink called immunonutrition can help reduce painful swallowing (esophagitis) caused by radiation therapy for lung cancer. It is for patients with non-small cell or small cell lung cancer who are about to receive radiation therapy to the chest. Participants will receive either the special nutrition drink or standard care, and will be monitored for side effects. Standard care may involve pain medication or other supportive treatments for esophagitis. The trial aims to enroll 121 participants.

Official Summary

This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have been diagnosed with lung cancer, and need radiation therapy to your chest. You must be able to eat and drink normally and have good general health as indicated by specific blood test results. You cannot join if you have had radiation to your chest before, have a history of esophageal cancer, or are currently experiencing severe reflux. Pregnant or breastfeeding women, and those with certain severe medical conditions like heart disease or active autoimmune diseases, cannot participate. This trial is studying Non Small Cell Lung Cancer, Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if the special nutrition drink reduces the number of patients who develop moderate to severe throat pain and difficulty swallowing. The specific primary outcome measures are: Incidence rate of grade 2 or higher acute esophagitis (3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a common and difficult side effect of lung cancer radiation, aiming to improve patient quality of life during treatment. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non Small Cell Lung Cancer, Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in lung cancer care, with potential to become a standard supportive therapy, indicating a market for improved patient supportive care products. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you and what the potential benefits and risks are. If you join, you will receive either the special nutrition drink or standard care, and will have regular check-ups to monitor your health and side effects. The special nutrition drink is taken by mouth, usually twice a day, starting on the day radiation begins and continuing for three weeks after. This trial is currently recruiting participants. The trial is being conducted at 6 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 121 participants

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 Outcomes

• Incidence rate of grade 2 or higher acute esophagitis (3 months)

Secondary Outcomes

• Incidence rate of grade 2 or higher acute esophagitis (3 months)
• Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria (3 months)
• Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria (3 months)
• Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA） (3 months)
• Body weight (3 months)

Full Eligibility 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.

Trial Locations

• Hunan Cancer Hospital, Changsha, Hunan, China
• Third Xiangya Hospital, Central South University, Changsha, Hunan, China
• Xiangya Hospital of Central South University,, Changsha, Hunan, China
• The First People's Hospital of Chenzhou, Chenzhou, Hunan, China
• The Fisrt Affilated Hospital of University of South China, Hengyang, Hunan, China
• Yueyang Central Hospital, Yueyang, Hunan, China

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Thoracic Radiotherapy
• Esophagitis
• Radiation Therapy Side Effects
• Oncology
• Nutritional Support
• Cancer Supportive Care
• Gastrointestinal Disorders

More Non Small Cell Lung Cancer Trials

View all Non Small Cell Lung Cancer clinical trials