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Incidence and Factors Associated With the Development and Severity of Oral Mucositis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
Collaborator:
South Texas Veterans Health Care System
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00575809
First received: December 15, 2007
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Peripheral Blood Stem Cell Transplantation
Other: Mucositis and nutritional assessments

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Incidence and Factors Associated With the Development and Severity of Oral Mucositis in Patients Undergoing High-Dose Chemotherapy and Peripheral Blood Stem Cell Transplantation

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • To evaluate the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obsevational Other: Mucositis and nutritional assessments
Mucositis and nutritional assessments before and during the hematopoietic stem cell transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing hematopoietic stem cell transplantation

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575809

Contacts
Contact: Juan J Toro, MD, MS 210-617-5300 ext 16777 juan.toro2@va.gov

Locations
United States, Texas
Department of Veterans Affairs, South Texas Veterans Health Care System, Audie L. Murphy Memorial Veterans Hospital Division Recruiting
San Antonio, Texas, United States, 78229
Contact: Juan J Toro, MD    210-617-5300 ext 16777    juantoro2@va.gov   
Principal Investigator: Juan J Toro, MD         
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Juan J Toro, MD    210-617-5300 ext 16777    juantoro2@va.gov   
Principal Investigator: Juan J Toro, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
South Texas Veterans Health Care System
Investigators
Principal Investigator: Cesar O Freytes, MD South Texas Veterans Health Care System
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00575809     History of Changes
Other Study ID Numbers: HSC20050218H
Study First Received: December 15, 2007
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Mucositis, hematopoietic stem cell transplantation, chemotherapy

Additional relevant MeSH terms:
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 24, 2014