JPRN-jRCTs051220167招募中2 期
A randomized trial to evaluate the nutritional support with ISOCAL CLEAR and rehabilitation on prevention of skeletal muscle mass loss -a pilot study
Kiyoshi Maeda0 个研究点目标入组 40 人开始时间: 2023年2月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
- •(2)Stage II-III
- •(3)Aged 20 years and older.
- •(4)ECOG Performance status 0 or 1.
- •(5)oral intake is possible
- •(6)Major organ function is preserved.
- •(7)Witten informed consent is obtained.
排除标准
- •(1)Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
- •(2)Active infection requiring systemic therapy.
- •(3)Fever over 38 degrees Celsius
- •(4)Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
- •(5)Psychological disorder difficult to participate in this clinical study.
- •(6)Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents.
- •(7)Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
- •(8)Uncontrolled arterial hypertension.
- •(9)Drug history of opioids, or stroids.
- •(10)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
- •(11) Allergy for milk (or protein from milk)
- •(12) Other reason why principal investigator considered ineligible
研究者
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