This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
121
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.
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGThird Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGXiangya Hospital of Central South University,
Changsha, Hunan, China
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
Incidence rate of grade 2 or higher acute esophagitis
Assessed according to RTOG toxicity criteria.
Time frame: 3 months
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
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
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
Body weight
Time frame: 3 months
Nutritional Risk
Assessed according to Nutritional Risk Screening 2002 (NRS 2002)
Time frame: 3 months
The duration period of esophagitis
The number of days of grade 2 or higher esophagitis
Time frame: 3 months
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The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
RECRUITINGThe Fisrt Affilated Hospital of University of South China
Hengyang, Hunan, China
RECRUITINGYueyang Central Hospital
Yueyang, Hunan, China
RECRUITINGOpioid use
Measured by documented opioid use
Time frame: 3 months
Quality of life assessed by EORTC QLQ-C30
EORTC QLQ-C30 scores range from 0 to 100, with higher scores indicating a better quality of life.
Time frame: 3 months
Quality of life assessed by FACT-L
FACT-L scores range from 0 to 108, with higher scores indicating a better quality of life.
Time frame: 3 months
Quality of life assessed by FACT-E Eating and Swallowing Subscales
FACT-E Eating and Swallowing Subscales scores range from 0 to 68, with higher scores indicating a better quality of life.
Time frame: 3 months