Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy (Mucositis)

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: Infrared 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.

• Study Type: Observational
• Enrollment (Actual): 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group no mucositis; Control patients with multiple myeloma who are not currently receiving chemotherapy and who do not suffer from oral mucositis	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.
Non-control Group Mucositis; Patients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Emre Vural, MD, UAMS; Principal Investigator: Elias Anaissie, MD, UAMS; Principal Investigator: Gal Shafirstein, PhD, UAMS

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: October 8, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (ESTIMATE): December 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: 110227