Oral Zinc Therapy for the Prevention of Mucositis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- Maximal Mucositis grade [ Time Frame: day -7 to day +21 or discharge day ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Oral zinc therapy, intervention
Oral Zincol 1 Tab TID from day -6/-7 until discharge
Placebo Comparator: 2
Oral placebo 1 Tab TID from day -6/-7 until discharge
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,
|Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center|
|Principal Investigator:||Maya Koren-Michowitz, MD||Sheba Medical Center|