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Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

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ClinicalTrials.gov Identifier: NCT01015183
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Mucositis Bone Marrow Transplantation Drug: Zinc Sulfate Drug: Placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate
Study Start Date : November 2009
Primary Completion Date : November 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluation of Zinc Sulfate concentration [ Time Frame: 1 year ]
  2. Evaluation of Zinc Sulfate advance effects [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing bone marrow transplantation
  • Signed informed consent

Exclusion Criteria:

  • Unable take drug (or placebo) orally
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015183


Locations
Iran, Islamic Republic of
Hematology-Oncology & SCT Research Center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Molouk Hadjibabaie, PhD Hematology-Oncology and SCT Research Center
More Information

Additional Information:
Responsible Party: Mahdi Jalili MD / Hematology-Oncology and SCT Research Center, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01015183     History of Changes
Other Study ID Numbers: HORCSCT-0904
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Tehran University of Medical Sciences:
Mucositis
Bone Marrow Transplantation
BMT
HSCT

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents