Back to resultsOral Zinc Therapy for the Prevention of Mucositis
Primary Purpose
Mucositis
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Zinc
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis focused on measuring Stem cell transplantation, Mucositis, Zinc
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing high dose chemotherapy with stem cell support for relapsed or resistant Hodgkins or NHL (treated with BEAM protocol) or MM (treated with high dose melphalan).
- ECOG performance less than or equal to 2
- Adequate renal and hepatic function
Exclusion Criteria:
- Presence of any other active malignancy other than BCC of the skin
Sites / Locations
- Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Oral zinc therapy, intervention
oral placebo
Outcomes
Primary Outcome Measures
Maximal Mucositis grade
Secondary Outcome Measures
Duration of maximal mucositis grade
Overall duration of mucositis
Duration of severe neutropenia
Duration of febrile neutropenia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00449592
Brief Title
Oral Zinc Therapy for the Prevention of Mucositis
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
Keywords
Stem cell transplantation, Mucositis, Zinc
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral zinc therapy, intervention
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
oral placebo
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
Oral Zincol 1 Tab TID from day -6/-7 until discharge
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo 1 Tab TID from day -6/-7 until discharge
Primary Outcome Measure Information:
Title
Maximal Mucositis grade
Time Frame
day -7 to day +21 or discharge day
Secondary Outcome Measure Information:
Title
Duration of maximal mucositis grade
Time Frame
day -7 to day +21 or discharge day
Title
Overall duration of mucositis
Time Frame
day -7 to day +21 or discharge day
Title
Duration of severe neutropenia
Time Frame
day -7 to day +21 or discharge day
Title
Duration of febrile neutropenia
Time Frame
day -7 to day +21 or discharge day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing high dose chemotherapy with stem cell support for relapsed or resistant Hodgkins or NHL (treated with BEAM protocol) or MM (treated with high dose melphalan).
ECOG performance less than or equal to 2
Adequate renal and hepatic function
Exclusion Criteria:
Presence of any other active malignancy other than BCC of the skin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Koren-Michowitz, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center
City
Ramat-Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Oral Zinc Therapy for the Prevention of Mucositis
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