Oral Zinc Therapy for the Prevention of Mucositis - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00449592

Purpose

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	Intervention	Phase
Mucositis	Drug: Zinc Drug: Placebo	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Maximal Mucositis grade [ Time Frame: day -7 to day +21 or discharge day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of maximal mucositis grade [ Time Frame: day -7 to day +21 or discharge day ] [ Designated as safety issue: No ]
Overall duration of mucositis [ Time Frame: day -7 to day +21 or discharge day ] [ Designated as safety issue: No ]
Duration of severe neutropenia [ Time Frame: day -7 to day +21 or discharge day ] [ Designated as safety issue: No ]
Duration of febrile neutropenia [ Time Frame: day -7 to day +21 or discharge day ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

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,

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449592

Locations

Israel
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

More Information

Responsible Party:	Sheba Medical Center ( Dr. Maya Koren-Michovitz )
Study ID Numbers:	SHEBA-06-4196-MKM-CTIL
Study First Received:	March 18, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00449592
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Stem cell transplantation
Mucositis
Zinc

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Mucositis
Gastrointestinal Diseases

Zinc
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009