Clinical Trials Directory

Trials / Completed

CompletedNCT01036633

Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

Use of an Infrared Thermometer to Grade the Severity of Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

Status
Completed
Phase
Study type
Observational
Enrollment
4 (actual)
Sponsor
University of Arkansas · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

Summary

The purpose of this study was to: 1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy. 2. To obtain preliminary data on the most optimal method of scoring the severity of oral mucositis by comparing the results obtained using the IR thermometer to the World Health Organization (WHO) mucositis grading system and the patient self-assessment questionnaire. 3. To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.

Detailed description

Several grading systems for oral mucositis are available including those of the World Health Organization (WHO), Radiation Therapy Oncology Group (RTOG), Western Consortium for Cancer Nursing Research WCCNR, and the National Cancer Institute Common Toxicity Criteria (NCICTC) and others However, all of these oral mucositis grading systems rely on visual examination and are therefore subjective and operator-dependent tools and suffer from significant interpersonal variability (6). With the current improvements in medicine and technology, there is definitely a need for a more objective, easy to perform, non-invasive, affordable, quantitative and reproducible tool that is operator-independent to assess the severity of oral mucositis. The introduction of such a tool would greatly improve our ability to compare the oral mucosal toxicity of antineoplastic therapies and the efficacy of various mucoprotective therapies. Furthermore, the use of such a tool can be extended to patients undergoing radiation treatment with or without chemotherapy for various malignancies including head and neck cancers.

Conditions

Interventions

TypeNameDescription
DEVICEInfrared ThermometerThe infrared thermometer will be used to grade the severity of oral mucositis in patients undergoing antineoplastic chemotherapy for multiple myeloma. The photothermal camera will be used to take intraoral digital images of the mouth.

Timeline

Start date
2009-08-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2009-12-21
Last updated
2012-03-22

Source: ClinicalTrials.gov record NCT01036633. Inclusion in this directory is not an endorsement.