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Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

NCT03159845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-07

No results posted yet for this study

Summary

Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are performed on peripheral blood samples.

Conditions

  • Stem Cell Transplant Complications

Interventions

DRUG

Zinc Sulfate Oral Product

DRUG

Levofloxacin 500Mg Oral Tablet

once daily from day +10 until day +30 after stem cell transplantation

DRUG

Fluconazole 200mg tab

twice daily from day +10 until day +30 after stem cell transplantation

DRUG

Acyclovir 400 MG

twice daily from day +10 until day +30 after stem cell transplantation

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2019-09-10
Completion
2019-09-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159845 on ClinicalTrials.gov