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

NCT ID: NCT03159845

Last Updated: 2020-01-07

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

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2019-09-10

Brief Summary

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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.

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Detailed Description

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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. The aim of the study is to investigate the immune reconstitution in presence of Zinc, focused on thymic reconstitution. Laboratory tests are performed on peripheral blood samples, collected at 4 time-points: two before transplant (at the moment of the enrollment and the day before conditioning) and two after transplant (day +30 and +100).

Conditions

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Stem Cell Transplant Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Case-control study, open, without placebo
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

patients undergone autologous stem cell transplantation. They take levofloxacin 500 mg/d, aciclovir 400 mg bid, fluconazole 200 mg bid from day +10 until day +30 after stem cell transplantation

Group Type ACTIVE_COMPARATOR

Levofloxacin 500Mg Oral Tablet

Intervention Type DRUG

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

Fluconazole 200mg tab

Intervention Type DRUG

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

Acyclovir 400 MG

Intervention Type DRUG

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

Zinc

patients undergone autologous stem cell transplantation. They take the same antimicrobial prophylaxis of patients of the Control group, and, in addition, a daily oral supplementation of Zinc Sulfate, 600 mg/die, uncoated tabs, from day +5 until day +100 after transplant

Group Type EXPERIMENTAL

Zinc Sulfate Oral Product

Intervention Type DRUG

Levofloxacin 500Mg Oral Tablet

Intervention Type DRUG

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

Fluconazole 200mg tab

Intervention Type DRUG

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

Acyclovir 400 MG

Intervention Type DRUG

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

Interventions

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Zinc Sulfate Oral Product

Intervention Type DRUG

Levofloxacin 500Mg Oral Tablet

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

Intervention Type DRUG

Fluconazole 200mg tab

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

Intervention Type DRUG

Acyclovir 400 MG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* eligibility to stem cell transplantation

Exclusion Criteria

* allergy to Zinc
* copper deficiency or Wilson's syndrome
* patients who admit zinc assumption in other drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo Iovino

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hematology UO

Pisa, , Italy

Site Status

Countries

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Italy

References

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Iovino L, Mazziotta F, Carulli G, Guerrini F, Morganti R, Mazzotti V, Maggi F, Macera L, Orciuolo E, Buda G, Benedetti E, Caracciolo F, Galimberti S, Pistello M, Petrini M. High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation. Leuk Res. 2018 Jul;70:20-24. doi: 10.1016/j.leukres.2018.04.016. Epub 2018 May 2.

Reference Type DERIVED
PMID: 29747074 (View on PubMed)

Other Identifiers

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Hematology AOUPisa

Identifier Type: -

Identifier Source: org_study_id

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