Tocopherol is a Novel Treatment for Cancer Related Mucositis

Phase 2

Withdrawn

• Conditions: Oral Mucositis

• Registration Number: NCT00162526
• Lead Sponsor: Hadassah Medical Organization

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 chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Study Start: 2005-12
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the toxicity and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel