Tocopherol is a Novel Treatment for Cancer Related Mucositis
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
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|
- 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.
- 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.
|Study Start Date:||December 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162526
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Shimon Slavin, MD||Hadassah Medical Organization|