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
|Condition or disease||Intervention/treatment||Phase|
|Mucositis Hematopoietic Stem Cell Transplantation||Drug: Oral selenium Drug: Oral placebo||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Oral selenium therapy arm
Drug: Oral selenium
Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
Placebo Comparator: Placebo
Drug: Oral placebo
Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge
- 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
- 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 ]
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
|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|
|Study Chair:||Molouk Hadjibabaie, Pharma D||Tehran University of Medical Sciences|