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This study has been withdrawn prior to enrollment.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:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162526
First received: September 11, 2005
Last updated: April 7, 2011
Last verified: September 2005

September 11, 2005
April 7, 2011
December 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00162526 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Tocopherol is a Novel Treatment for Cancer Related Mucositis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Oral Mucositis
Drug: Tocopherol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00162526
270505-HMO-CTIL
Not Provided
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Hadassah Medical Organization
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP