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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Oral Mucositis
Both
Oral Mucositis
Trial Information
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
Inclusion Criteria:
- 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
marrow recovery.
- Karnofsky performance status of 60 or greater or ECOG performance status of 2 or
less.
- Normal dental examination as assessed by the investigator.
Exclusion Criteria:
- Clinically significant acute and active oral cavity infection.
- Patients taking any investigational or other non-approved oral therapy for oral
mucositis.
- Known hypersensitivity to Vitamin E.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Shimon Slavin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hadassah Medical Organization
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
270505-HMO-CTIL
NCT ID:
NCT00162526
Start Date:
December 2005
Completion Date:
Related Keywords:
- Oral Mucositis
- Stomatitis
- Mucositis
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