Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

July 25, 2011 updated by: Tehran University of Medical Sciences

Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient undergoing bone marrow transplantation
  • Signed informed consent

Exclusion Criteria:

  • Unable take drug (or placebo) orally

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Received Zinc Sulfate
Drug: Zinc Sulfate
Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy
Placebo Comparator: Control
Control group
Drug: Placebo
Placebo: as the same of intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Zinc Sulfate concentration
Time Frame: 1 year
1 year
Evaluation of Zinc Sulfate advance effects
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Molouk Hadjibabaie, PhD, Hematology-Oncology and SCT Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HORCSCT-0904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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