NCT06392971

Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis

A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital of Chengdu Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Radiotherapy is an important treatment for esophageal cancer, and acute radiation-induced esophagitis (ARIE) is the most common complication during radiotherapy. The present study was conducted to investigate the clinical efficacy of deep-sea fish oil in the prevention and treatment of ARIE, and to evaluate the effects of deep-sea fish oil on patients' nutritional status, quality of life, pain management, and the effect on the treatment. This is a prospective, single-center, randomized controlled clinical study. The present study has been registered in the Chinese Clinical Trials Registry (ChiCTR2200056847). The present study intends to continuously enroll 120 patients with esophageal cancer who are to receive radiotherapy, and randomly divide the enrolled patients into two groups. One group receive treatment of deep-sea fish oil and the other group is blank control. The differences of ARIE occurrence, ARIE degree, pain degree, and the changes of the inflammatory index were compared.

Conditions

• Radiation Toxicity
• Esophagitis
• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-03-15
• Completion: 2026-04-15
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: China