Evaluation of effects of topical solution of vitamin E in preventing oral mucositis in Allogenic Hematopoietic Stem Cell Transplantation patients

The aim of the current study is to find a new way to prevent the occurrence of mucositis and decrease its severity in recipients of hematopoietic stem cell transplant who receive conditioning regimen with the combination of Busulfan and Cyclophosphamide.

Two arm parallel,randomized double blind placebo controlled clinical trial

This study is going to take place in Bone Marrow Transplantation center of Tehran. Patients included in this study are supposed to receive a topical solution that contains Vitamin E or placebo, twice daily and be evaluated each day by the researcher in order to examine the effects of topical vitamin E on the occurrence and severity of the oral mucositis. Preparation of the topical solution is going to be done by department of Pharmaceutics in Faculty of Pharmacy. The chief of research and Pharmaceutics expert will be the only ones aware of the formulation content and will make proper decisions based on the circumstances.

Inclusion criteria: - Age more than 18 years - Receiving conditioning regimen with Busulfan and Cyclophosphamide Exclusion criteria: - Patients with active mucositis at the time of admission - Active bleeding - Any contraindications to vitamin E, including history of hypersensitivity reactions to drug or any component of the formulation

In this study, patients are going to be divided into two groups. patients in the test group will receive a topical solution that contains vitamin E 400 IU twice daily and are supposed to rinse their mouth with the solution and spit it out. The patients in the placebo group are going to receive an identical looking solution that does not contain vitamin E.

- Decreased incidence and severity of oral mucositis - Decreased need for narcotic pain killers - Decreased length of ward stay

The patients are going to be divided into blocks of 8 patients. For randomization a random numbers table is going to be utilized. Patients who will receive the odd numbers are going to be given the product labeled as number 1 and patients who will receive the even numbers are going to be given the product labeled as number 2. Allocation concealment is carried out by blinding the researcher.

In the current study, the pharmaceutical products containing drug or placebo are going to be formulated in Tehran University of Medical Sciences, Faculty of Pharmacy and delivered to the researcher. Neither the patient, attending nurse or researcher are going to be aware of which product contains the drug. The head of the clinical trial and pharmaceutics expert will be aware of the patients status including which one receives the drug or placebo and will make proper decisions to proceed with the trial or discontinue it based on situation and inform the related authorities.

Evaluation of effects of topical solution of vitamin E in preventing oral mucositis in allogenic Hematopoietic Stem Cell Transplantation patients.

the data of the study is anticipated to be available in 6/15/2019 and be available indefinitely

the plan is to publish the results of the research in valid data bases and make available for fellow researchers from different fields

the private data that belongs to patients is not going to be available to anyone and different analysis could be performed on the provided data under proper referencing rules.

publishable data or documents could be obtained by contacting through the following routes: - email: m-solduzian@razi.tums.ac.ir - phone number: 00989120920355

the request should be submitted to above mentioned e.mail or phone number, and the required information must be verified by the chief of research, then the data will be available only if ethic committee proves it is publishable.