NCT03159845

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

A Mono-centric, No-profit, Case-control Study With Daily Oral Supplementation of Zinc Sulphate After Autologous Stem Cell Transplantation in Patients Affected by Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Stem Cell Transplant Complications

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-09-10
• Completion: 2019-09-10
• First posted: 2017-05-19
• Last updated: 2020-01-07

Locations

1 site across 1 country: Italy