NCT00575809

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

16.2 years

First QC Date

December 15, 2007

Last Update Submit

July 19, 2021

Conditions

Peripheral Blood Stem Cell Transplantation

Keywords

Mucositis, hematopoietic stem cell transplantation, chemotherapy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation

    10 years

Study Arms (1)

Obsevational

Other: Mucositis and nutritional assessments

Interventions

Mucositis and nutritional assessmentsOTHER

Mucositis and nutritional assessments before and during the hematopoietic stem cell transplantation

Obsevational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing hematopoietic stem cell transplantation

You may qualify if:

  • Patients undergoing hematopoietic stem cell transplantation
  • Age 18 years and older
  • Patients must understand and sign the study informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Veterans Affairs, South Texas Veterans Health Care System, Audie L. Murphy Memorial Veterans Hospital Division

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Mucositis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Cesar O Freytes, MD

    South Texas Veterans Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2007

First Posted

December 18, 2007

Study Start

May 1, 2005

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

US(2)