Clinical trial NCT01036633: Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
Official title: Use of an Infrared Thermometer to Grade the Severity of Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Mucositis
Keywords: mucositis
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis

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.

Eligibility criteria: 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

Primary outcomes:
measure: To investigate the feasibility of using an infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy
timeFrame: 24 months
Secondary outcomes:
measure: Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer.
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: UAMS
name: Emre Vural, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UAMS
name: Elias Anaissie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UAMS
name: Gal Shafirstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: