JPRN-jRCTs051180026已完成2 期
Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT Non-synbiotics vs synbiotics
Minami Hironobu0 个研究点目标入组 12 人开始时间: 2019年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
Our study suggests that Gfine can be given safely and may be effective against gastrointestinal toxicity in the patients received high-dose chemotherapy with autologous peripheral blood stem cell transplantation. Because our study is a pilot study, future studies with a larger number of patients are required.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •(1) Malignant lymphoma who can be candidate for autologous PBSCT
- •(2) 17(3) ECOG PS <2
- •(4) No obvious organ failure
- •(5) They have given written informed consent
- •(6) Patients who will survive more than 3 months
排除标准
- •(1) History of stem cell transplantation
- •(2) HIV carrier
- •(3) Uncontrolled active infectious diseases
- •(4) Pregnant or lactating
- •(5) Uncontrolled psychological disorder
- •(6) Allergy for the drugs used for the conditioning regimen
- •(7) Allergy for Gfine
- •(8) Patients who do not tolerate the maximal defined conditioning regimen due to organ dysfunction (e.g., reduce MCNU due to pulmonary dysfunction, reduce Carboplatin due to renal dysfunction)
- •(9) Patients who do not ingest enough calories
- •(10) Investigator rejection
研究者
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