Oral Selenium Therapy for the Prevention of Mucositis

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01432873

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Mucositis Hematopoietic Stem Cell Transplantation	Drug: Oral selenium Drug: Oral placebo	Phase 1/Phase 2

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Oral selenium therapy arm	Drug: Oral selenium Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
Placebo Comparator: Placebo Oral placebo	Drug: Oral placebo Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge

Arm

Intervention/Treatment

Experimental: Experimental

Oral selenium therapy arm

Drug: Oral selenium

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

Placebo Comparator: Placebo

Oral placebo

Drug: Oral placebo

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology-Oncology & SCT Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair: Molouk Hadjibabaie, Pharma D, Tehran University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01432873

Other Study ID Numbers:

HORCSCT-9001

First Posted:

Sep 13, 2011

Last Update Posted:

Jun 4, 2012

Last Verified:

May 1, 2012

Keywords provided by Tehran University of Medical Sciences

BMT

HSCT

Additional relevant MeSH terms:

Mucositis

Selenium

Study Results

No Results Posted as of Jun 4, 2012