- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575809
Incidence and Factors Associated With the Development and Severity of Oral Mucositis
Incidence and Factors Associated With the Development and Severity of Oral Mucositis in Patients Undergoing High-Dose Chemotherapy and Peripheral Blood Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- The University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Department of Veterans Affairs, South Texas Veterans Health Care System, Audie L. Murphy Memorial Veterans Hospital Division
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing hematopoietic stem cell transplantation
- Age 18 years and older
- Patients must understand and sign the study informed consent
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Obsevational
|
Mucositis and nutritional assessments before and during the hematopoietic stem cell transplantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Cesar O Freytes, MD, South Texas Veterans Health Care System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20050218H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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