Oral Selenium Therapy for the Prevention of Mucositis

NCT ID: NCT01432873

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

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

Conditions

Mucositis; Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Oral selenium therapy arm

Group Type: EXPERIMENTAL

Oral selenium

Intervention Type: DRUG

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

Placebo

Oral placebo

Group Type: PLACEBO_COMPARATOR

Oral placebo

Intervention Type: DRUG

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

Interventions

Oral selenium

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

Intervention Type: DRUG

Oral placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Molouk Hadjibabaie, Pharma D

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Locations

Hematology-Oncology & SCT Research Center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Facility Contacts

Molouk Hadjibabaie, Pharma D.

Role: primary

+989122838464

References

Jahangard-Rafsanjani Z, Gholami K, Hadjibabaie M, Shamshiri AR, Alimoghadam K, Sarayani A, Mojtahedzadeh M, Ostadali-Dehaghi M, Ghavamzadeh A. The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial. Bone Marrow Transplant. 2013 Jun;48(6):832-6. doi: 10.1038/bmt.2012.250. Epub 2013 Jan 7.

Reference Type: DERIVED

PMID: 23292233 (View on PubMed)

Other Identifiers

HORCSCT-9001

Identifier Type: -

Identifier Source: org_study_id