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

Phase 2

Recruiting

• Conditions: Esophageal Cancer; Radiation Toxicity; Esophagitis
• Interventions: Drug: Deep-sea fish oil; Other: Placebo

• Registration Number: NCT06392971
• Lead Sponsor: First Affiliated Hospital of Chengdu Medical College

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.

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 Timeline

• Study Start: 2023-01-15
• Primary Completion: 2024-03-15
• Status Verified: 2024-04
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age ≥18 years old, ≤70 years old, gender is not limited;
2. Histological or cytological evidence of esophageal, lung, or breast cancer;
3. ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
4. Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
5. PG-SGA score <9;
6. Not pregnant or breastfeeding;
7. The subject must understand and sign the informed consent
8. Have reading comprehension ability and can complete the questionnaire with medical assistance;
9. Those who voluntarily participate in the study and sign the informed consent letter in person.

Exclusion Criteria

1. Prior radiation therapy;
2. Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;
3. Pregnant or lactating female patients;
4. Suffering from severe mental illness and poor compliance;
5. Other cases deemed unsuitable for inclusion by the researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive use of deep-sea fish oil	Deep-sea fish oil	-
Preventive use of placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Severity of acute radiation esophagitis	Approximately 2 months	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.
The duration from initiation of radiotherapy to the onset of acute radiation esophagitis	Approximately 2 months
Incidence of severe acute radiation esophagitis	Approximately 2 months

Secondary Outcome Measures

Name	Time	Method
The concentration of plasma IL-6	Approximately 2 months	The concentrations of plasma IL-6 were measured at the beginning of radiotherapy, completion of 10 fractionated radiotherapy, and completion of 20 fractionated radiotherapy.
Pain degree	Approximately 2 months	For patients with acute radiation esophagitis in the two groups, the Numerical Rating Scale (NRS) pain scoring method was used to evaluate the pain degree daily from the first day of acute radiation esophagitis, which was usually divided into the following criteria: 0 score: no pain 2; Scores 1-3: mild pain; 4-6 points: moderate pain; Score 7-10: Severe pain. The NRS score is based on a 10-point scale of pain, and the patient makes a numerical score to let the doctor know the level and level of pain.
The concentration of plasma C-reactive protein	Approximately 2 months	The concentrations of plasma C-reactive protein were measured at three-time points at the beginning of radiotherapy, completion of 10 fractionated radiotherapy, and completion of 20 fractionated radiotherapy.

Trial Locations

Locations (1)

The First Affiliated Hospital of Chengdu Medical College; 🇨🇳 Chengdu, China