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Oral Zinc Therapy for the Prevention of Mucositis

NCT ID: NCT00449592

Last Updated: 2008-10-03

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Patients candidate for High dose chemotherapy with stem cell support for the diagnosis of relapsed/resistant Hodgkins or NHL or MM will be screened for enrollment in the study.

Patients will be randomized in a 1:1 ratio to therapy with either zincol 1 Tab TID or placebo 1 Tab TID.

Therapy will start on the morning before commencing chemotherapy and will continue untill the first of either discharge day or day 21.

Response assesment will include:

1. Mucositis assesment using NCI-CTC and OMAS scores- to be done eod from baseline and untill day 21/discharge day if before day 21
2. Evaluation of zinc levels in the serum, PBMC and saliva- to be done at baseline, day 6/7 and day 21/discharge day if before day 21.
3. Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia,use of antibacterial and antifungal medications,

Conditions

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Mucositis

Keywords

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Stem cell transplantation Mucositis Zinc

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Oral zinc therapy, intervention

Group Type EXPERIMENTAL

Zinc

Intervention Type DRUG

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

2

oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Zinc

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Presence of any other active malignancy other than BCC of the skin
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Maya Koren-Michowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-06-4196-MKM-CTIL

Identifier Type: -

Identifier Source: org_study_id