Oral Selenium Therapy for the Prevention of Mucositis

Phase 1

• Conditions: Mucositis; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Oral selenium; Drug: Oral placebo

• Registration Number: NCT01432873
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Oral selenium	Oral selenium therapy arm
Placebo	Oral placebo	Oral placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hematology-Oncology & SCT Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of