Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria
研究概览
简要总结
This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 18-65 years
- •histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010)
- •receipt of definitive CCRT
- •Eastern Cooperative Oncology Group performance status of 0-1
- •creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula
- •absence of mucositis
- •able to tolerate oral feeding
排除标准
- •receipt of curative surgery for HNC
- •allergies to any component of the immunonutrition
结局指标
主要结局
Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria
时间窗: 6 weeks after initiation of concurrent chemoradiation (CCRT)
Proportion of severe oral mucositis between two groups
次要结局
- serum albumin in grams per deciliter (g/dL)(6 weeks after initiation of CCRT and 1 month after CCRT completion)
- body weight in kilograms(6 weeks after initiation of CCRT and 1 month after CCRT completion)
- Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria(through study completion, an average of 6 weeks)
- C-reactive protein (CRP) in milligrams per liter (mg/L)(6 weeks after initiation of CCRT and 1 month after CCRT completion)
- progression-free survival (PFS)(at 3 years)
- hemoglobin in grams per deciliter (g/dL)(6 weeks after initiation of CCRT and 1 month after CCRT completion)
- neutrophil-to-lymphocyte ratio (NLR)(6 weeks after initiation of CCRT and 1 month after CCRT completion)
- actual dose of radiation in centigrays (cGy)(through study completion, an average of 6 weeks)
- cumulative dose of cisplatin in milligrams per square meter (mg/m2)(through study completion, an average of 6 weeks)
- platelet-to-lymphocyte ratio (PLR)(6 weeks after initiation of CCRT and 1 month after CCRT completion)
- overall survival (OS)(at 3 years)
研究者
Arunee Dechaphunkul
Assistant Professor
Prince of Songkla University