Oral Selenium Therapy for the Prevention of Mucositis
Açar sözlər
Mücərrəd
Təsvir
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
Tarixlər
| Son Doğrulandı: | 04/30/2012 |
| İlk təqdim: | 07/24/2011 |
| Təxmini qeydiyyat təqdim edildi: | 09/11/2011 |
| İlk Göndərmə: | 09/12/2011 |
| Son Yeniləmə Göndərildi: | 05/30/2012 |
| Son Yeniləmə Göndərildi: | 06/03/2012 |
| Həqiqi Təhsilin Başlama Tarixi: | 05/31/2011 |
| Təxmini İlkin Tamamlanma Tarixi: | 09/30/2012 |
| Təxmini İşin Tamamlanma Tarixi: | 11/30/2012 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Experimental
Drug: Placebo
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Experimental: Experimental Oral selenium therapy arm | Drug: Experimental Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge |
| Placebo Comparator: Placebo Oral placebo | Drug: Placebo Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | 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 |
Nəticə
İlkin nəticə tədbirləri
1. The grade of oral mucositis after bone marrow transplantation [Participants will be followed for the duration of hospital stay, an expected average of 3 weeks]
İkincili Nəticə Tədbirləri
1. Evaluation of selenium concentration and glutathione peroxidase level in serum [up to 3 weeks]
2. Total days of mucositis after BMT [Participants will be followed for the duration of hospital stay, an expected average of 3 weeks]
