Oral Selenium Therapy for the Prevention of Mucositis

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01432873

Enrollment

Registered

2011-09-13

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation, Mucositis

Keywords

BMT, HSCT

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

Interventions

DRUGOral selenium

Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge

DRUGOral placebo

Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation

Secondary

Measure	Time frame
Evaluation of selenium concentration and glutathione peroxidase level in serum	up to 3 weeks
Total days of mucositis after BMT	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026