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Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01015183
First received: November 17, 2009
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Mucositis
Bone Marrow Transplantation
Drug: Zinc Sulfate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of Zinc Sulfate concentration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluation of Zinc Sulfate advance effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: November 17, 2009
Last Updated: July 25, 2011
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014