Oral Zinc Therapy for the Prevention of Mucositis
|Study Design:||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|
- Maximal Mucositis grade [ Time Frame: day -7 to day +21 or discharge day ]
- Duration of maximal mucositis grade [ Time Frame: day -7 to day +21 or discharge day ]
- Overall duration of mucositis [ Time Frame: day -7 to day +21 or discharge day ]
- Duration of severe neutropenia [ Time Frame: day -7 to day +21 or discharge day ]
- Duration of febrile neutropenia [ Time Frame: day -7 to day +21 or discharge day ]
|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,
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449592
|Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center|
|Principal Investigator:||Maya Koren-Michowitz, MD||Sheba Medical Center|