Back to resultsPrevention Chemotherapy Induced Mucositis by Zinc Sulfate
Primary Purpose
Mucositis, Bone Marrow Transplantation
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Zinc Sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mucositis focused on measuring Mucositis, Bone Marrow Transplantation, BMT, HSCT
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing bone marrow transplantation
- Signed informed consent
Exclusion Criteria:
- Unable take drug (or placebo) orally
Sites / Locations
- Hematology-Oncology & SCT Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Received Zinc Sulfate
Control group
Outcomes
Primary Outcome Measures
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
Secondary Outcome Measures
Evaluation of Zinc Sulfate concentration
Evaluation of Zinc Sulfate advance effects
Full Information
NCT ID
NCT01015183
First Posted
November 17, 2009
Last Updated
July 25, 2011
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01015183
Brief Title
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate
Official Title
Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Bone Marrow Transplantation
Keywords
Mucositis, Bone Marrow Transplantation, BMT, HSCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Received Zinc Sulfate
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Zinc Sulfate
Intervention Description
Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: as the same of intervention group
Primary Outcome Measure Information:
Title
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of Zinc Sulfate concentration
Time Frame
1 year
Title
Evaluation of Zinc Sulfate advance effects
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient undergoing bone marrow transplantation
Signed informed consent
Exclusion Criteria:
Unable take drug (or placebo) orally
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molouk Hadjibabaie, PhD
Organizational Affiliation
Hematology-Oncology and SCT Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology-Oncology & SCT Research Center
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate
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