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Oral Selenium Therapy for the Prevention of Mucositis

This study is currently recruiting participants.
Verified May 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01432873
First received: July 25, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Mucositis
Hematopoietic Stem Cell Transplantation
 Drug: Oral selenium
Drug: Oral placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Total days of mucositis after BMT [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432873

Locations
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
Investigators
Study Chair: Molouk Hadjibabaie, Pharma D Tehran University of Medical Sciences
  More Information

Additional Information:
Hematology-Oncology & SCT Research Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01432873     History of Changes
Other Study ID Numbers: HORCSCT-9001
Study First Received: July 25, 2011
Last Updated: May 31, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
BMT
HSCT

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Selenium
Trace Elements
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013