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Tocopherol is a Novel Treatment for Cancer Related Mucositis

This study has been withdrawn prior to enrollment.
(the PI is no longer work at Hadassah)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162526
First Posted: September 13, 2005
Last Update Posted: April 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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.

Condition Intervention Phase
Oral Mucositis Drug: Tocopherol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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.

Estimated Enrollment: 30
Study Start Date: December 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162526


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00162526     History of Changes
Other Study ID Numbers: 270505-HMO-CTIL
First Submitted: September 11, 2005
First Posted: September 13, 2005
Last Update Posted: April 8, 2011
Last Verified: September 2005

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances


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