Oral Selenium Therapy for the Prevention of Mucositis

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01432873
• Other study ID #: HORCSCT-9001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 25, 2011
• Last updated: May 31, 2012
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation
• Mucositis

Intervention

Drug:
• Oral selenium
Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
• Oral placebo
Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hematology-Oncology & SCT Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of selenium concentration and glutathione peroxidase level in serum		up to 3 weeks	No
Secondary	Total days of mucositis after BMT		Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No

External Links

•   Hematology-Oncology & SCT Research Center