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NCT01015183 Clinical Trial

Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

Mucositis Clinical Trial

Official title:
Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01015183
Other study ID # HORCSCT-0904
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 17, 2009
Last updated July 25, 2011
Start date November 2009
Est. completion date June 2011

Study information
Verified date July 2011
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient undergoing bone marrow transplantation

- Signed informed consent

Exclusion Criteria:

- Unable take drug (or placebo) orally

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Zinc Sulfate
Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy
• Placebo
Placebo: as the same of intervention group

Locations
Country Name City State
Iran, Islamic Republic of Hematology-Oncology & SCT Research Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation 1 year No
Secondary Evaluation of Zinc Sulfate concentration 1 year No
Secondary Evaluation of Zinc Sulfate advance effects 1 year No
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