Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)
研究概览
简要总结
The purpose of this study is to determine efficacy and toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive chemotherapy with stem cell transplantation in patients with hematologic malignancies.
详细描述
Oral mucositis is one of the most common adverse events during chemotherapy and affects quality of life of patients receiving chemotherapy in relation to the dose of drugs. However, there is only one drug (palifermin) approved by the US FDA for the prevention of oral mucositis and the other methods to prevent or treat oral mucositis are just empirical and lack evidences. The results of recent study demonstrated promising efficacy and minimal toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral mucositis in head and neck cancer patients undergoing radiotherapy (Wu HG, et al. Cancer 2009;115(16):3699-3708). This clinical trial is a double-blind randomized prospective single-institutional phase II study to evaluate efficacy and toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive chemotherapy with stem cell transplantation in patients with hematologic malignancies.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of hematologic malignancies including acute & chronic leukemia, lymphoma, plasma cell dyscrasia, myelodysplastic syndrome, aplastic anemia, etc.
- •Patients who are planned to receive high-dose chemotherapy with SCT
- •ECOG performance status 0-2
- •Informed consent
排除标准
- •Patients having previous history of hypersensitivity to this drug or similar drugs
- •Patients having oral ulcer or herpes or severe dental disease at the time of inclusion
- •Patients received chemotherapy, radiotherapy, or surgery within 3 weeks
- •Patients who had finished clinical trials which could affect the results of this trial within 4 weeks or are attending one at the time of inclusion
- •Patients having another diseases which have worse prognosis than patients' hematologic malignancy
- •Patients with major psychotic disorder or drug/alcohol abuser
- •Women who are pregnant or breastfeeding
- •Refusal at patients' will
- •Inappropriate patients according to the investigators' opinion
研究组 & 干预措施
EGF
rhEGF + povidone iodine, chlorhexidine, & nystatin
干预措施: rhEGF + povidone iodine, chlorhexidine, & nystatin (Drug)
Placebo
Placebo + povidone iodine, chlorhexidine, & nystatin
干预措施: Placebo + povidone iodine, chlorhexidine, & nystatin (Drug)
结局指标
主要结局
Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)
时间窗: Assessed daily during application of study drugs
次要结局
- Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (WHO)(Assessed daily during application of study drugs)
- Adverse events(Assessed daily during application of study drugs)
- Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (NCI CTCAE 3.0)(Assessed daily during application of study drugs)
- OMDQ (oral mucositis daily questionnaire) score during treatment(Assessed daily during application of study drugs)
- Day of onset and duration of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)(Assessed daily during application of study drugs)
- Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO)(Assessed daily during application of study drugs)
- Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO)(Assessed daily during application of study drugs)
研究者
Sung-Soo Yoon
Professor
Seoul National University Hospital