JPRN-UMIN000016453已完成2 期
The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients - The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •i. Opioid use before initiation of chemoradiotherapy ii. Use of AboundTM before initiation of chemoradiotherapy iii. Patients who will receive palliative chemoradiotherapy iv. Serious comorbidities include the following: a. Renal failure b. Disseminated intravascular coagulation c. Acute thrombocytopenia d. Chronic obstructive pulmonary disease e. Interstitial pneumonia f. Severe heart disease, such as ischemic heart disease and arrhythmia v. Women who are pregnant, contemplating pregnancy or amid breast-feeding. vi. Mental disorders which is considered inappropriate for inclusion in the study. vii. Continuous systemic treatment with corticosteroids viii. Signs of acute bacterial or fungus infection ix. Protein intake restriction x. Patients who are taking supplement or drugs containing Arginine or Glutamine, and who will continue to take them throughout the chemotherapy xi. Hypersensitivity to the element of AboundTM xii. Unable to take AboundTM per oral or per PEG xiii. Any other cases who are regarded as inadequate for study enrollment by the investigator
研究者
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