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Oral Selenium Therapy for the Prevention of Mucositis

Primary Purpose

Mucositis, Hematopoietic Stem Cell Transplantation

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Oral selenium
Oral placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring BMT, HSCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation
  • Adequate renal and hepatic function

Exclusion Criteria:

  • Taking selenium supplement before admission

Sites / Locations

  • Hematology-Oncology & SCT Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Oral selenium therapy arm

Oral placebo

Outcomes

Primary Outcome Measures

The grade of oral mucositis after bone marrow transplantation
The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation

Secondary Outcome Measures

Evaluation of selenium concentration and glutathione peroxidase level in serum
Total days of mucositis after BMT

Full Information

First Posted
July 25, 2011
Last Updated
May 31, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01432873
Brief Title
Oral Selenium Therapy for the Prevention of Mucositis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Patients with AML or ALL diagnosis, candidates for high dose chemotherapy with stem cell transplantation will be screened for enrollment in the study. Patients will be randomized in two groups with balanced block randomization method. One group will receive selenium tablet twice per day and another group will receive placebo two times per day.Therapy will start on the morning before starting chemotherapy and will continue until the first of either discharge day or day +21. Response assessment will include: Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21. Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14. Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Hematopoietic Stem Cell Transplantation
Keywords
BMT, HSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Oral selenium therapy arm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo
Intervention Type
Drug
Intervention Name(s)
Oral selenium
Intervention Description
Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
Intervention Type
Drug
Intervention Name(s)
Oral placebo
Intervention Description
Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge
Primary Outcome Measure Information:
Title
The grade of oral mucositis after bone marrow transplantation
Description
The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary Outcome Measure Information:
Title
Evaluation of selenium concentration and glutathione peroxidase level in serum
Time Frame
up to 3 weeks
Title
Total days of mucositis after BMT
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation Adequate renal and hepatic function Exclusion Criteria: Taking selenium supplement before admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molouk Hadjibabaie, Pharma D
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology-Oncology & SCT Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molouk Hadjibabaie, Pharma D.
Phone
+989122838464
First Name & Middle Initial & Last Name & Degree
Molouk Hadjibabaie, Pharma D
First Name & Middle Initial & Last Name & Degree
Zahra Jahangard rafsanjani, Pharma D

12. IPD Sharing Statement

Citations:
PubMed Identifier
23292233
Citation
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.
Results Reference
derived

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Oral Selenium Therapy for the Prevention of Mucositis

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