ACTRN12606000083594尚未招募2 期
A multicentre, double blind, placebo controlled, safety and efficacy trial of whey growth factor extract (WGFEA) for oral mucositis in lymphoma patients undergoing carmustine, etoposide, cytosine arabinoside and melphalan (BEAM) chemotherapy and autologous stem cell transplantation
TGR Biosciences0 个研究点目标入组 60 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Have a diagnosis of lymphoma and due to undergo high-dose BEAM chemotherapy and autologous stem cell transplantation which will be managed primarily as an inpatient. 2. Have a life expectancy of at least 2 months, in the opinion of the investigator. 3. Clinical laboratory values deemed by the investigator to be acceptable to undergo stem cell transplantation. 4. Eastern Cooperative Oncology Group (ECOG) performance status less than 3 (Section 5.2.3).17. 5. Able to provide written informed consent to participate in this trial. 6. Able to understand and comply with the requirements of the trial; be able to abide with the restrictions and return for their required treatments and evaluations without undue hardship.
排除标准
- •Patients with any of the following conditions will be excluded from participation in this trial:1. Medically documented allergies to dairy products.2. Any visual signs of oral mucosal damage or trauma prior to starting the trial treatments.3. Oesophageal, stomach or primary (un-resected) cancer of the colon or rectum.4. Cancer of the oral cavity or tongue.5. An active condition, not chemotherapy-related, causing mucositis or mucosal ulceration such as oral Herpes or Candida infection.6. Intend to use dental appliances including mouth guards or braces during the treatment period. Subjects with dentures may be enrolled.7. Females who are pregnant or breastfeeding. Females who are menstruating and of child bearing potential must use medically approved contraception (i.e., oral contraceptive agents, diaphragm plus spermicide, condom, intrauterine device) one month before, during and one month after the trial.8. Currently use other investigational agents (drug or device) or have received an investigational agent (drug or device) within 30 days of screening.9. Deemed by the investigator or nominee to be uncooperative or unsuitable for inclusion into this trial.10. ave participated in this trial previously and/or who dropped out or were withdrawn.11. Have uncontrolled diabetes.12. Currently use or have received palifermin (Kepivance, AMGEN) for managing oral mucositis within 90 days of screening.
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