NCT00449592

Brief Summary

Zinc is an intracellular mineral with important enzymatic cofactor activities for cell membrane stability, DNA and RNA structure. Zinc deficiency is associated with delayed wound healing and immune dysfunction. In patietns with hematological malignancies an inverse correlation was found between disease stage and zinc level. Patients undergoing high dose chemotherapy for hematologic malignancies are predisposed to develop oral and gastrointestinal complications, in particular oral mucositis. These patients may have relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of these complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 3, 2008

Status Verified

October 1, 2008

Enrollment Period

1.4 years

First QC Date

March 18, 2007

Last Update Submit

October 2, 2008

Conditions

Mucositis

Keywords

Stem cell transplantationMucositisZinc

Outcome Measures

Primary Outcomes (1)

  • Maximal Mucositis grade

    day -7 to day +21 or discharge day

Secondary Outcomes (4)

  • Duration of maximal mucositis grade

    day -7 to day +21 or discharge day

  • Overall duration of mucositis

    day -7 to day +21 or discharge day

  • Duration of severe neutropenia

    day -7 to day +21 or discharge day

  • Duration of febrile neutropenia

    day -7 to day +21 or discharge day

Study Arms (2)

1

EXPERIMENTAL

Oral zinc therapy, intervention

Drug: Zinc

2

PLACEBO COMPARATOR

oral placebo

Drug: Placebo

Interventions

ZincDRUG

Oral Zincol 1 Tab TID from day -6/-7 until discharge

1
PlaceboDRUG

Oral placebo 1 Tab TID from day -6/-7 until discharge

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing high dose chemotherapy with stem cell support for relapsed or resistant Hodgkins or NHL (treated with BEAM protocol) or MM (treated with high dose melphalan).
  • ECOG performance less than or equal to 2
  • Adequate renal and hepatic function

You may not qualify if:

  • Presence of any other active malignancy other than BCC of the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Mucositis

Interventions

Zinc

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Maya Koren-Michowitz, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 18, 2007

First Posted

March 20, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 3, 2008

Record last verified: 2008-10

Locations

IL(1)