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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age ≥18 years old, ≤70 years old, gender is not limited;

• Histological or cytological evidence of esophageal, lung, or breast cancer;

• ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;

• Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;

• PG-SGA score \<9;

• Not pregnant or breastfeeding;

• The subject must understand and sign the informed consent

• Have reading comprehension ability and can complete the questionnaire with medical assistance;

• Those who voluntarily participate in the study and sign the informed consent letter in person.

Locations
Other Locations
China
The First Affiliated Hospital of Chengdu Medical College
RECRUITING
Chengdu
Contact Information
Primary
Ke Xu, Doctor
xuke@cmc.edu.cn
Backup
Yanqiu Yang, Doctor
285965467@qq.com
86+02883016171
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 120
Treatments
Experimental: Preventive use of deep-sea fish oil
Placebo_comparator: Preventive use of placebo
Sponsors
Leads: First Affiliated Hospital of Chengdu Medical College

This content was sourced from clinicaltrials.gov

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