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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
Sponsor:
Information provided by:
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Mucositis Drug: Zinc Drug: Placebo Phase 4

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:

  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 medications,

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Oral zinc therapy, intervention
Drug: Zinc
Oral Zincol 1 Tab TID from day -6/-7 until discharge

Placebo Comparator: 2
oral placebo
Drug: Placebo
Oral placebo 1 Tab TID from day -6/-7 until discharge




Primary Outcome Measures :
  1. Maximal Mucositis grade [ Time Frame: day -7 to day +21 or discharge day ]

Secondary Outcome Measures :
  1. Duration of maximal mucositis grade [ Time Frame: day -7 to day +21 or discharge day ]
  2. Overall duration of mucositis [ Time Frame: day -7 to day +21 or discharge day ]
  3. Duration of severe neutropenia [ Time Frame: day -7 to day +21 or discharge day ]
  4. Duration of febrile neutropenia [ Time Frame: day -7 to day +21 or discharge day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Israel
Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center
Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Maya Koren-Michowitz, MD Sheba Medical Center
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Responsible Party: Dr. Maya Koren-Michovitz, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00449592    
Other Study ID Numbers: SHEBA-06-4196-MKM-CTIL
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: October 3, 2008
Last Verified: October 2008
Keywords provided by Sheba Medical Center:
Stem cell transplantation
Mucositis
Zinc
Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases