Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

Completed

• Conditions: Oral Mucositis
• Interventions: Device: Infrared Thermometer

• Registration Number: NCT01036633
• Lead Sponsor: University of Arkansas

Brief 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer.	24 months