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Oral Selenium Therapy for the Prevention of Mucositis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Tehran University of Medical Sciences Identifier:
First received: July 25, 2011
Last updated: May 31, 2012
Last verified: May 2012
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 Intervention Phase
Hematopoietic Stem Cell Transplantation
Drug: Oral selenium
Drug: Oral placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Evaluation of selenium concentration and glutathione peroxidase level in serum [ Time Frame: 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 ]

Estimated Enrollment: 76
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01432873

Iran, Islamic Republic of
Hematology-Oncology & SCT Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Molouk Hadjibabaie, Pharma D.    +989122838464      
Principal Investigator: Molouk Hadjibabaie, Pharma D         
Sub-Investigator: Zahra Jahangard rafsanjani, Pharma D         
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Chair: Molouk Hadjibabaie, Pharma D Tehran University of Medical Sciences
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences Identifier: NCT01432873     History of Changes
Other Study ID Numbers: HORCSCT-9001
Study First Received: July 25, 2011
Last Updated: May 31, 2012

Keywords provided by Tehran University of Medical Sciences:

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances processed this record on April 28, 2017