Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449592
Status:
COMPLETED
Last Update Posted:
2008-10-03
First Post:
2007-03-18
Brief Title:
Oral Zinc Therapy for the Prevention of Mucositis
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Patients candidate for High dose chemotherapy with stem cell support for the diagnosis of relapsedresistant Hodgkins or NHL or MM will be screened for enrollment in the study
Patients will be randomized in a 11 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 21discharge day if before day 21
2 Evaluation of zinc levels in the serum PBMC and saliva- to be done at baseline day 67 and day 21discharge day if before day 21
3 Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropeniause of antibacterial and antifungal medications
Patients will be randomized in a 11 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 21discharge day if before day 21
2 Evaluation of zinc levels in the serum PBMC and saliva- to be done at baseline day 67 and day 21discharge day if before day 21
3 Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropeniause of antibacterial and antifungal medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None