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IRCT20180416039325N1 IRCT 2018-07-25 Tehran University of Medical Sciences Effects of topical vitamin E solution in mucositis Evaluation of effects of topical solution of vitamin E in preventing oral mucositis in Allogenic Hematopoietic Stem Cell Transplantation patients 2018-07-23 anticipated 80 Complete https://irct.ir/trial/31589 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Oral mucositis. Intervention group: Patients in the intervention group are supposed to receive vitamin E mouth wash solution, that contain 400 IU of the drug in each dose, twice daily and be evaluated daily by the researcher in order to find the effects of vitamin E on the incidence and severity of oral mucositis. The mouth wash solution contains glycerin, sodium chloride, sodium benzoate and polysorbate 20 in water base.. Yes - There is a plan to make this available What will be shared: Evaluation of effects of topical solution of vitamin E in preventing oral mucositis in allogenic Hematopoietic Stem Cell Transplantation patients. When: the data of the study is anticipated to be available in 6/15/2019 and be available indefinitely To whom: the plan is to publish the results of the research in valid data bases and make available for fellow researchers from different fields Conditions: 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. Where to obtain: publishable data or documents could be obtained by contacting through the following routes: - email: m-solduzian@razi.tums.ac.ir - phone number: 00989120920355 How to obtain: 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. Comments:
public Moluk Haji Babayi
North Kargar st, Jalal st, Sahriaty Hospital, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 m-solduzian@razi.tums.ac.ir Tehran University of Medical Sciences scientific Moluk Haji Babayi
North Kargar st, Jalal st, Sahriaty Hospital, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 m-solduzian@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age older than 18 years Receiving conditioning regimen with Busulfan and Cyclophosphamide 18 years no limit Both Showing active mucositis signs and symptoms at the time of admission Active bleeding Any contraindication to vitamin E as hypersensitivity reactions K12.3 Oral mucositis (ulcerative) Prevention Intervention group: Patients in the intervention group are supposed to receive vitamin E mouth wash solution, that contain 400 IU of the drug in each dose, twice daily and be evaluated daily by the researcher in order to find the effects of vitamin E on the incidence and severity of oral mucositis. The mouth wash solution contains glycerin, sodium chloride, sodium benzoate and polysorbate 20 in water base. Incidence of oral mucositis. Timepoint: Daily for 15 days which is the duration that patient receives the formulation. Method of measurement: Clinical evaluation based on National Cancer Institute Common Terminology Criteria for Adverse Effects version 4.0 scale. Severity of oral mucositis. Timepoint: Daily for 15 days which is the duration that patient receives the formulation. Method of measurement: Clinical evaluation based on National Cancer Institute Common Terminology Criteria for Adverse Effects version 4.0 scale. Duration of Bone Marrow Transplant ward stay. Timepoint: From the day of admission to Bone Marrow Transplant ward until discharge form the ward. Method of measurement: Medical records. The need for narcotic analgesic. Timepoint: From the day of admission to Bone Marrow Transplant ward until discharge form the ward. Method of measurement: Medical records. Tehran University of Medical Sciences Approved 2018-05-06 Ethics committee of Tehran University of Medical Sciences North Kargar st, Jalal st, Sahriaty Hospital, Hematology- Oncology and Bone Marrow Transplant Center,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)