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Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy (Mucositis)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01036633
First Posted: December 21, 2009
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
October 8, 2009
December 21, 2009
March 22, 2012
August 2009
July 2011   (Final data collection date for primary outcome 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 [ Time Frame: 24 months ]
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 ]
Complete list of historical versions of study NCT01036633 on ClinicalTrials.gov Archive Site
Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer. [ Time Frame: 24 months ]
Investigating the correlation between the quantitative readings obtained from oral mucosa with photothermal camera and the IR thermometer. [ Time Frame: 12 months ]
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Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis
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.
  • Control Group no mucositis
    Control patients with multiple myeloma who are not currently receiving chemotherapy and who do not suffer from oral mucositis
    Intervention: Device: Infrared Thermometer
  • Non-control Group Mucositis
    Patients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis
    Intervention: Device: Infrared Thermometer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01036633
110227
No
Not Provided
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University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Emre Vural, MD UAMS
Principal Investigator: Elias Anaissie, MD UAMS
Principal Investigator: Gal Shafirstein, PhD UAMS
University of Arkansas
March 2012