Back to resultsTocopherol is a Novel Treatment for Cancer Related Mucositis
Primary Purpose
Oral Mucositis
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Tocopherol
Sponsored by
About this trial
This is an interventional treatment trial for Oral Mucositis
Eligibility Criteria
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.
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00162526
First Posted
September 11, 2005
Last Updated
April 7, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00162526
Brief Title
Tocopherol is a Novel Treatment for Cancer Related Mucositis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Withdrawn
Why Stopped
the PI is no longer work at Hadassah
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tocopherol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Slavin, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Tocopherol is a Novel Treatment for Cancer Related Mucositis
We'll reach out to this number within 24 hrs