Tocopherol is a Novel Treatment for Cancer Related Mucositis

Hadassah Medical Center

Status and phase

Withdrawn

Phase 2

Conditions

Oral Mucositis

Treatments

Drug: Tocopherol

Study type

Interventional

Funder types

Other

Identifiers

NCT00162526

270505-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.