Oral Selenium Therapy for the Prevention of Mucositis
A Randomized Double Blinded Placebo Controlled Oral Selenium Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
76
1 country
1
Brief Summary
Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Our purpose in this double blinded randomized study is to evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia (AML) \& acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 4, 2012
May 1, 2012
1.3 years
July 25, 2011
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The grade of oral mucositis after bone marrow transplantation
The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary Outcomes (2)
Evaluation of selenium concentration and glutathione peroxidase level in serum
up to 3 weeks
Total days of mucositis after BMT
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Study Arms (2)
Experimental
EXPERIMENTALOral selenium therapy arm
Placebo
PLACEBO COMPARATOROral placebo
Interventions
Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
Eligibility Criteria
You may qualify if:
- Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation
- Adequate renal and hepatic function
You may not qualify if:
- Taking selenium supplement before admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hematology-Oncology & SCT Research Center
Tehran, Iran
Related Publications (1)
Jahangard-Rafsanjani Z, Gholami K, Hadjibabaie M, Shamshiri AR, Alimoghadam K, Sarayani A, Mojtahedzadeh M, Ostadali-Dehaghi M, Ghavamzadeh A. The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial. Bone Marrow Transplant. 2013 Jun;48(6):832-6. doi: 10.1038/bmt.2012.250. Epub 2013 Jan 7.
PMID: 23292233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Molouk Hadjibabaie, Pharma D
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2011
First Posted
September 13, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
June 4, 2012
Record last verified: 2012-05