Oral Zinc Therapy for the Prevention of Mucositis
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|ClinicalTrials.gov Identifier: NCT00449592|
Recruitment Status : Completed
First Posted : March 20, 2007
Last Update Posted : October 3, 2008
|Condition or disease||Intervention/treatment||Phase|
|Mucositis||Drug: Zinc Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||April 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449592
|Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center|
|Principal Investigator:||Maya Koren-Michowitz, MD||Sheba Medical Center|