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Oral Selenium Therapy for the Prevention of Mucositis

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ClinicalTrials.gov Identifier: NCT01432873
Recruitment Status : Unknown
Verified May 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 13, 2011
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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:

  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  (Clinical Trial)
Estimated 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 : June 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

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




Primary Outcome Measures :
  1. 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 :
  1. Evaluation of selenium concentration and glutathione peroxidase level in serum [ Time Frame: up to 3 weeks ]
  2. Total days of mucositis after BMT [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01432873     History of Changes
Other Study ID Numbers: HORCSCT-9001
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: May 2012

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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances