Status:
WITHDRAWN
Tocopherol is a Novel Treatment for Cancer Related Mucositis
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradioth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00162526
Start Date
December 1 2005
Last Update
April 8 2011
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120