A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Severity of acute radiation esophagitis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Other cases deemed unsuitable for inclusion by the researchers.
研究组 & 干预措施
Preventive use of deep-sea fish oil
干预措施: Deep-sea fish oil (Drug)
Preventive use of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Severity of acute radiation esophagitis
时间窗: 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
时间窗: Approximately 2 months
Incidence of severe acute radiation esophagitis
时间窗: Approximately 2 months
次要结局
- The concentration of plasma IL-6(Approximately 2 months)
- Pain degree(Approximately 2 months)
- The concentration of plasma C-reactive protein(Approximately 2 months)