Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation (CTRC# 20050218H)
Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement.
Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period.
Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.