NCT01432873

Oral Selenium Therapy for the Prevention of Mucositis

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21. 2. Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14. 3. Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications

Conditions

• Mucositis
• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Oral selenium	Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
DRUG	Oral placebo	Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-09-13
• Last updated: 2012-06-04

Locations

1 site across 1 country: Iran