Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

Официальное название

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

Обзор

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

Подробное описание

This is a prospective, randomized, controlled, open-label clinical trial, which aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute esophagitis after thoracic radiotherapy in lung cancer patients.

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

• Incidence rate of grade 2 or higher acute esophagitis [Срок оценки: 3 months]

Вторичные конечные точки (11)

• Incidence rate of grade 2 or higher acute esophagitis [Срок оценки: 3 months]
• Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria [Срок оценки: 3 months]
• Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria [Срок оценки: 3 months]
• Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA） [Срок оценки: 3 months]
• Body weight [Срок оценки: 3 months]
• Nutritional Risk [Срок оценки: 3 months]
• The duration period of esophagitis [Срок оценки: 3 months]
• Opioid use [Срок оценки: 3 months]
• Quality of life assessed by EORTC QLQ-C30 [Срок оценки: 3 months]
• Quality of life assessed by FACT-L [Срок оценки: 3 months]
• Quality of life assessed by FACT-E Eating and Swallowing Subscales [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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 creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).

• 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).

Критерии исключения

• 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 subjects 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, 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 6 центров

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

Идентификаторы

NCT: NCT06840704 · IIT128

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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