Clinical trial NCT01432873: Oral Selenium Therapy for the Prevention of Mucositis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Mucositis
Hematopoietic Stem Cell Transplantation
Keywords: BMT
HSCT
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: The grade of oral mucositis after bone marrow transplantation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: Evaluation of selenium concentration and glutathione peroxidase level in serum
timeFrame: up to 3 weeks
measure: Total days of mucositis after BMT
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
Study officials:
affiliation: Tehran University of Medical Sciences
name: Molouk Hadjibabaie, Pharma D
role: STUDY_CHAIR
References:
citation: Jahangard-Rafsanjani Z, Gholami K, Hadjibabaie M, Shamshiri AR, Alimoghadam K, Sarayani A, Mojtahedzadeh M, Ostadali-Dehaghi M, Ghavamzadeh A. The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial. Bone Marrow Transplant. 2013 Jun;48(6):832-6. doi: 10.1038/bmt.2012.250. Epub 2013 Jan 7.