Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
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Purpose
The purpose of this study was to:
- To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy.
- 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.
- To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.
| Condition | Intervention |
|---|---|
|
Oral Mucositis |
Device: Infrared Thermometer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Use of an Infrared Thermometer to Grade the Severity of Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy |
- 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 ] [ Designated as safety issue: No ]
- Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | August 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01036633 History of Changes |
| Other Study ID Numbers: | 110227 |
| Study First Received: | October 8, 2009 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
mucositis |
Additional relevant MeSH terms:
|
Stomatitis Mucositis Mouth Diseases Stomatognathic Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013