Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

NCT ID: NCT01015183

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mucositis Bone Marrow Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Received Zinc Sulfate

Group Type EXPERIMENTAL

Zinc Sulfate

Intervention Type DRUG

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

Control

Control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: as the same of intervention group

Interventions

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Zinc Sulfate

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

Intervention Type DRUG

Placebo

Placebo: as the same of intervention group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing bone marrow transplantation
* Signed informed consent

Exclusion Criteria

* Unable take drug (or placebo) orally
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Molouk Hadjibabaie, PhD

Role: PRINCIPAL_INVESTIGATOR

Hematology-Oncology and SCT Research Center

Locations

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Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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HORCSCT-0904

Identifier Type: -

Identifier Source: org_study_id

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