A Randomized Double Blind Placebo Controlled Clinical Trial Aim to Assess the Efficacy of Vitamin E Formulation (Tocopherol) in the Treatment of Chemotherapy Induced Stomatitis in Patients Undergoing Stem Cell Transplantation
- Males and non-pregnant and non-lactating females, 18 years of age or older at the
time of screening, who are to receive myeloablative agonists with or without total
body irradiation (TBI) in preparation for either allogeneic or autologous HSCT.
Patients who are to be hospitalized and are expected to remain hospitalized until
- Karnofsky performance status of 60 or greater or ECOG performance status of 2 or
- Normal dental examination as assessed by the investigator.
- Clinically significant acute and active oral cavity infection.
- Patients taking any investigational or other non-approved oral therapy for oral
- Known hypersensitivity to Vitamin E.
Type of Study:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To evaluate the tolerability and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.
Shimon Slavin, MD
Hadassah Medical Organization
Israel: Israeli Health Ministry Pharmaceutical Administration
- Oral Mucositis