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Completed

NCT Number: NCT01015183

Prevention Chemotherapy Induced Mucositis by 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.

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Key information

Conditions

Mucositis Bone Marrow Transplantation Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing bone marrow transplantation
  • Signed informed consent

Exclusion criteria

  • Unable take drug (or placebo) orally

Treatment and study plan

zinc sulfate

Drug

Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy

Placebo

Drug

Placebo: as the same of intervention group

Primary outcomes

  1. The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation

    Time frame: 1 year

Secondary outcomes

  1. Evaluation of Zinc Sulfate concentration

    Time frame: 1 year

  2. Evaluation of Zinc Sulfate advance effects

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 18, 2009
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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