NCT00068276已完成2 期
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.
PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Determine the efficacy of cholecalciferol, in terms of hematological improvement, in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine the effect of this drug on disease symptoms, fatigue, and the overall health-related quality of life of these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive oral cholecalciferol once daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed myelodysplastic syndromes (MDS)
- •Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months
- •International Prognostic Scoring System score of 0 or 1
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 1 year
- •Hematopoietic
- •Not specified
- •Not specified
- •No history of hypercalcemia
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior stem cell transplantation allowed
- •No concurrent hematopoietic growth factors
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 6 weeks since prior cholecalciferol supplements or analogs
- •More than 4 weeks since any prior therapy for MDS (except supportive care)
- •No other concurrent therapy for MDS
排除标准
- 未提供
研究者
研究点 (1)
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