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
| Type | Name | Description |
|---|---|---|
| DEVICE | Infrared Thermometer | The 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.