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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral zinc therapy, intervention |
|
| 2 | Placebo Comparator | oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Drug | Oral Zincol 1 Tab TID from day -6/-7 until discharge |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Mucositis grade | day -7 to day +21 or discharge day |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of maximal mucositis grade | day -7 to day +21 or discharge day | |
| Overall duration of mucositis | day -7 to day +21 or discharge day | |
| Duration of severe neutropenia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya Koren-Michowitz, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center | Ramat Gan | Israel |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Drug |
Oral placebo 1 Tab TID from day -6/-7 until discharge |
|
| day -7 to day +21 or discharge day |
| Duration of febrile neutropenia | day -7 to day +21 or discharge day |
| D009057 |
| Stomatognathic Diseases |
| D008670 |
| Metals |