Clinical trial NCT00449592: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mucositis
Keywords: Stem cell transplantation
Mucositis
Zinc
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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,

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

Primary outcomes:
measure: Maximal Mucositis grade
timeFrame: day -7 to day +21 or discharge day
Secondary outcomes:
measure: Duration of maximal mucositis grade
timeFrame: day -7 to day +21 or discharge day
measure: Overall duration of mucositis
timeFrame: day -7 to day +21 or discharge day
measure: Duration of severe neutropenia
timeFrame: day -7 to day +21 or discharge day
measure: Duration of febrile neutropenia
timeFrame: day -7 to day +21 or discharge day
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Maya Koren-Michowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: