Oral Zinc Therapy for the Prevention of Mucositis

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00449592

Collaborator

(none)

Enrollment

Location

Arms

17.1

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mucositis	Drug: Zinc Drug: Placebo	Phase 4

Detailed Description

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:

Mucositis assesment using NCI-CTC and OMAS scores- to be done eod from baseline and untill day 21/discharge day if before day 21
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.
Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia,use of antibacterial and antifungal medications,

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Ramdomized Double Blined Placebo Controlled Oral Zinc Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Stem Cell Support

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Oral zinc therapy, intervention	Drug: Zinc Oral Zincol 1 Tab TID from day -6/-7 until discharge
Placebo Comparator: 2 oral placebo	Drug: Placebo Oral placebo 1 Tab TID from day -6/-7 until discharge

Arm

Intervention/Treatment

Experimental: 1

Oral zinc therapy, intervention

Drug: Zinc

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

Placebo Comparator: 2

oral placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Maximal Mucositis grade [day -7 to day +21 or discharge day]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center	Ramat-Gan		Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator: Maya Koren-Michowitz, MD, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00449592

Other Study ID Numbers:

SHEBA-06-4196-MKM-CTIL

First Posted:

Mar 20, 2007

Last Update Posted:

Oct 3, 2008

Last Verified:

Oct 1, 2008

Keywords provided by , ,

Stem cell transplantation

Mucositis

Zinc

Additional relevant MeSH terms:

Mucositis

Study Results

No Results Posted as of Oct 3, 2008