Oral Zinc Therapy for the Prevention of Mucositis

Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449592
• Other study ID #: SHEBA-06-4196-MKM-CTIL
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2007
• Last updated: October 2, 2008
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis

Intervention

Drug:
• Zinc
Oral Zincol 1 Tab TID from day -6/-7 until discharge
• Placebo
Oral placebo 1 Tab TID from day -6/-7 until discharge

Locations

Country	Name	City	State
Israel	Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Mucositis grade		day -7 to day +21 or discharge day	No
Secondary	Duration of maximal mucositis grade		day -7 to day +21 or discharge day	No
Secondary	Overall duration of mucositis		day -7 to day +21 or discharge day	No
Secondary	Duration of severe neutropenia		day -7 to day +21 or discharge day	No
Secondary	Duration of febrile neutropenia		day -7 to day +21 or discharge day	No