Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study was to: To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy. 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. To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.

Detailed Description
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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.

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Device: Infrared Thermometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple Myeloma receiving chemotherapy Grade 3/4 Mucositis Exclusion Criteria: Women of child bearing potential who are unable to take adequate contraceptive precautions, have + pregnancy test w/in 24 hrs prior to study, pregnant, currently breastfeeding will not be able to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group no mucositis<br>Control patients with multiple myeloma who are not currently receiving chemotherapy and who do not suffer from oral mucositis | Device: Infrared Thermometer<br>* 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.<br>|
| Non-control Group Mucositis<br>Patients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis | Device: Infrared Thermometer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the feasibility of using an infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucositis