Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392971
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-25
Brief Title:
Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
Sponsor:
First Affiliated Hospital of Chengdu Medical College
Organization:
First Affiliated Hospital of Chengdu Medical College
Study Overview
Official Title:
A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PurposeTo observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis ARIE
Methods and MaterialsA total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned 11 to treatment or control group In the treatment group 1g deep-sea fish oil was oral administrated prophylactically twice a daythe 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
Methods and MaterialsA total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned 11 to treatment or control group In the treatment group 1g deep-sea fish oil was oral administrated prophylactically twice a daythe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None