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

Azienda Ospedaliero, Universitaria Pisana

Status and phase: Completed; Phase 2

Conditions: Stem Cell Transplant Complications

Treatments: Drug: Fluconazole 200mg tab; Drug: Acyclovir 400 MG; Drug: Levofloxacin 500Mg Oral Tablet; Drug: Zinc Sulfate Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03159845

Hematology AOUPisa

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Drug: Acyclovir 400 MG

Drug: Fluconazole 200mg tab

Drug: Levofloxacin 500Mg Oral Tablet

Zinc

Experimental group

Description:

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

Treatment:

Drug: Acyclovir 400 MG

Drug: Fluconazole 200mg tab

Drug: Zinc Sulfate Oral Product

Drug: Levofloxacin 500Mg Oral Tablet