Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00575809 |
| Other study ID # |
HSC20050218H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2005 |
| Est. completion date |
July 15, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
The University of Texas Health Science Center at San Antonio |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Objective: 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.
Clinical relevance: Mucositis is, without a doubt, one of the most common and debilitating
complications resulting from the intense cytotoxic therapies preceding hematopoietic stem
cell transplantation. Mucositis is not only a problem for the patient who needs to deal with
the pain and the rapidly decreasing quality of life, but it is also a problem for the health
system. Mucositis frequently results in increased hospital length of stay, resulting in a
significant increase in the cost of medical care. Multiple prophylactic and therapeutic
attempts have been made in order to control the symptoms and the severity of mucositis. No
prevention or cure is available for the disease. Despite the renewed interest in this
complication, important gaps in knowledge remain in this area of the supportive care of
cancer patients. These gaps in knowledge are wider in the area of mucositis in patients who
undergo hematopoietic stem cell transplantation.
