Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 120 |
| Updated: | 8/12/2018 |
| Start Date: | July 2003 |
| End Date: | September 2006 |
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
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.
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.
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.
- 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.
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:
Age
- Any age
Performance status
- Any
Life expectancy
- More than 1 year
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- 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
Surgery
- Not specified
Other
- 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
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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