Oral Selenium Therapy for the Prevention of Mucositis

Study Overview
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Brief Summary
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Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Our purpose in this double blinded randomized study is to evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia (AML) & acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT).

Detailed Description
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Patients with AML or ALL diagnosis, candidates for high dose chemotherapy with stem cell transplantation will be screened for enrollment in the study. Patients will be randomized in two groups with balanced block randomization method. One group will receive selenium tablet twice per day and another group will receive placebo two times per day.Therapy will start on the morning before starting chemotherapy and will continue until the first of either discharge day or day +21. Response assessment will include: Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21. Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14. Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications

Official Title
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A Randomized Double Blinded Placebo Controlled Oral Selenium Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Hematopoietic Stem Cell Transplantation

Conditions
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Mucositis, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Oral selenium
* Drug: Oral placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation Adequate renal and hepatic function Exclusion Criteria: Taking selenium supplement before admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Oral selenium therapy arm | Drug: Oral selenium<br>* Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge<br>|
| Placebo Comparator: Placebo<br>Oral placebo | Drug: Oral placebo<br>* Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The grade of oral mucositis after bone marrow transplantation | The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of selenium concentration and glutathione peroxidase level in serum |  | up to 3 weeks | 
| Total days of mucositis after BMT |  | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMT, HSCT