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This study has been withdrawn prior to enrollment.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)
Information provided by:
Hadassah Medical Organization
First received: September 11, 2005
Last updated: April 7, 2011
Last verified: September 2005
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.
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
||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
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:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162526
|Hadassah Medical Organization
|Jerusalem, Israel, 91120 |
Hadassah Medical Organization
||Shimon Slavin, MD
||Hadassah Medical Organization
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 11, 2005
||April 7, 2011
||Israel: Israeli Health Ministry Pharmaceutical Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs