Health TrialsbyHealthPanel

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

ConditionsNon Small Cell Lung CancerSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Cancer Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral immunonutrition

    Dietary supplement

    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.

Treatment groups

121 Participants
are divided into 2 treatment groups
Group A: Oral immunonutritionExperimental treatment 1 intervention
Group B: Standard nutritionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence rate of grade 2 or higher acute esophagitis

Assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Time frame
3 months

Secondary outcomes

1

Incidence rate of grade 2 or higher acute esophagitis

Assessed according to RTOG toxicity criteria.

Time frame
3 months
2

Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria

Assessed according to NCI-CTCAE v5.0 criteria

Time frame
3 months
3

Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria

Assessed according to RTOG toxicity criteria

Time frame
3 months
4

Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）

PG-SGA scores range from 0 to 35, with higher scores indicating a greater risk of severe malnutrition.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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