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Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01015183
Enrollment
60
Registered
2009-11-18
Start date
2009-11-30
Completion date
2011-06-30
Last updated
2011-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplantation, Mucositis

Keywords

Mucositis, Bone Marrow Transplantation, BMT, HSCT

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.

Interventions

DRUGZinc Sulfate

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

DRUGPlacebo

Placebo: as the same of intervention group

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patient undergoing bone marrow transplantation * Signed informed consent

Exclusion criteria

* Unable take drug (or placebo) orally

Design outcomes

Primary

MeasureTime frame
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation1 year

Secondary

MeasureTime frame
Evaluation of Zinc Sulfate concentration1 year
Evaluation of Zinc Sulfate advance effects1 year

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026