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

NCT06392971 | Recruiting Phase 2

• 1 other identifier: 23LCYJ049
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Toxicity; Esophagitis; Esophageal Cancer

Keywords

Fish oil; Acute Radiation-induced Esophagitis; Esophageal Cancer; prevention

Outcome Measures

Primary Outcomes (3)

• The duration from initiation of radiotherapy to the onset of acute radiation esophagitis

  Approximately 2 months

• Severity of acute radiation esophagitis

  Using the Radiation Therapy Oncology Group (RTOG) grading method for radiation esophagitis, patients with acute radiation esophagitis are evaluated daily from the first day onwards. Specifically, level 0: asymptomatic; Grade I: mild dysphagia or pain in swallowing, requiring topical or non-narcotic analgesia; Grade II: moderate dysphagia or swallowing pain, requiring narcotic analgesia; Grade III: severe dysphagia or dysphagia pain, accompanied by dehydration or weight loss greater than 15%, requiring a nasal feeding diet with intravenous fluids or high nutrients; Grade IV: complete obstruction, accompanied by ulceration, perforation, and fistula.

  Approximately 2 months

• Incidence of severe acute radiation esophagitis

  Approximately 2 months

Secondary Outcomes (3)

• Pain degree

  Approximately 2 months

• The concentration of plasma C-reactive protein

  Approximately 2 months

• The concentration of plasma IL-6

  Approximately 2 months

Study Arms (2)

Preventive use of deep-sea fish oil

EXPERIMENTAL

Drug: Deep-sea fish oil

Preventive use of placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Deep-sea fish oil DRUG

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.

Preventive use of deep-sea fish oil

Placebo OTHER

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.

Preventive use of placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior radiation therapy;
• Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;
• Pregnant or lactating female patients;
• Suffering from severe mental illness and poor compliance;

Sponsors & Collaborators

• First Affiliated Hospital of Chengdu Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Chengdu Medical College

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Esophagitis; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Wounds and Injuries; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Central Study Contacts

Ke Xu, Doctor

CONTACT

xuke@cmc.edu.cn

Yanqiu Yang, Doctor

CONTACT

86+02883016171; 285965467@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, randomized controlled clinical study. 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 Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: January 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)