A Ramdomized Double Blined Placebo Controlled Oral Zinc Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Stem Cell Support
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Maximal Mucositis grade
day -7 to day +21 or discharge day
Maya Koren-Michowitz, MD
Sheba Medical Center
Israel: Israeli Health Ministry Pharmaceutical Administration