Clinical Trial: Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: University of Arkansas

Current Primary Outcome: To investigate the feasibility of using an infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy [ Time Frame: 24 months ]

Original Primary Outcome: To investigate the feasibility of using photothermal camera and infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy [ Time Frame: 12 months ]

Current Secondary Outcome: Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer. [ Time Frame: 24 months ]

Original Secondary Outcome: Investigating the correlation between the quantitative readings obtained from oral mucosa with photothermal camera and the IR thermometer. [ Time Frame: 12 months ]

Information By: University of Arkansas

Dates:
Date Received: October 8, 2009
Date Started: August 2009
Date Completion:
Last Updated: March 21, 2012
Last Verified: March 2012