Oral Selenium Therapy for the Prevention of Mucositis

May 31, 2012 updated by: Tehran University of Medical Sciences

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Hematology-Oncology & SCT Research Center
        • Contact:
          • Molouk Hadjibabaie, Pharma D.
          • Phone Number: +989122838464
        • Principal Investigator:
          • Molouk Hadjibabaie, Pharma D
        • Sub-Investigator:
          • Zahra Jahangard rafsanjani, Pharma D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The grade of oral mucositis after bone marrow transplantation
Time Frame: 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
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of selenium concentration and glutathione peroxidase level in serum
Time Frame: up to 3 weeks
up to 3 weeks
Total days of mucositis after BMT
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (ESTIMATE)

September 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HORCSCT-9001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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