Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Mucositis; Bone Marrow Transplantation

Treatments: Drug: Placebo; Drug: Zinc Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01015183

HORCSCT-0904

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing bone marrow transplantation
• Signed informed consent

Exclusion criteria

• Unable take drug (or placebo) orally

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Received Zinc Sulfate

Treatment:

Drug: Zinc Sulfate

Control

Placebo Comparator group

Description:

Control group

Treatment:

Drug: Placebo