Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
Mucositis
Use of an Infrared Thermometer to Grade the Severity of Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
1 other identifier
observational
4
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMarch 22, 2012
March 1, 2012
1.9 years
October 8, 2009
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer.
24 months
Study Arms (2)
Control Group no mucositis
Control patients with multiple myeloma who are not currently receiving chemotherapy and who do not suffer from oral mucositis
Non-control Group Mucositis
Patients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis
Interventions
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.
Eligibility Criteria
Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis
You may qualify if:
- Multiple Myeloma receiving chemotherapy Grade 3/4 Mucositis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emre Vural, MD
UAMS
- PRINCIPAL INVESTIGATOR
Elias Anaissie, MD
UAMS
- PRINCIPAL INVESTIGATOR
Gal Shafirstein, PhD
UAMS
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2009
First Posted
December 21, 2009
Study Start
August 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
March 22, 2012
Record last verified: 2012-03