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Completed

NCT Number: NCT00449592

Oral Zinc Therapy for the Prevention of Mucositis

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.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Hematology and Bone Marrow Transplantation, Sheba Medical Center

Ramat Gan, Israel

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

Drug

Oral Zincol 1 Tab TID from day -6/-7 until discharge

Placebo

Drug

Oral placebo 1 Tab TID from day -6/-7 until discharge

Primary outcomes

  1. Maximal Mucositis grade

    Time frame: day -7 to day +21 or discharge day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 20, 2007
Registry last updated
Oct 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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