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Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
Sponsor: First Affiliated Hospital of Chengdu Medical College
Summary
Purpose：To observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (ARIE). Methods and Materials：A total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned (1:1) to treatment or control group. In the treatment group, 1g deep-sea fish oil was oral administrated prophylactically twice a day，the control group was blank control. The clinical efficacy of deep-sea fish oil on prevention of ARIE was evaluated by comparing the differences in the occurrence time, the grade and incidence of ARIE. Additionally, the change in nutritional status was also investigated. Hemanalysis, liver function, kidney function changes， and adverse reactions were compared before and after treatment to evaluate the safety of deep-sea fish oil.
Official title: A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-01-15
Completion Date
2026-04-15
Last Updated
2024-05-01
Healthy Volunteers
No
Interventions
Deep-sea fish oil
Starting from radiotherapy, the whole course of prophylactic oral deep-sea fish oil should be taken at the recommended dosage of 1g po bid according to the instructions (the administration method is to take it with the drug, remove the film on the drug surface, slowly swallow it in a supine position, and make the liquid fully contact with the esophageal mucosa). If no acute radioactive esophagus was assessed during the course of treatment, the patient was administered orally until the end of radiotherapy. If the patient developed radioactive esophagitis during the course of treatment, the relevant outcome measures were recorded and used as the endpoint event of the phase I study. The end point for patients without acute radiation esophagitis was at the completion of radiation therapy.
Placebo
Take a capsule made of food oil that looks like deep-sea fish oil at a dose of 1g po bid. Treatment is discontinued when patients develop acute radiation esophagitis.
Locations (1)
The First Affiliated Hospital of Chengdu Medical College
Chengdu, China