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CompletedNCT01036633MucositisUpdated Mar 22, 2012

Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

An observational study in Oral Mucositis, sponsored by University of Arkansas. Completed. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-22.

Sponsored by University of Arkansas · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
4
Ages
18 Years to 85 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Oral Mucositis

Keywords

  • mucositis
03

In context

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 4 is below the median of 102 across 66 observational studies indexed under Mucositis.

Browse Mucositis studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis

Inclusion criteria

  • Multiple Myeloma receiving chemotherapy Grade 3/4 Mucositis

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
4 participants (actual)

Groups and cohorts

  • 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

  • Non-control Group Mucositis

    Patients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis

    Device: Infrared Thermometer

Interventions

  • DeviceInfrared 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.

06

What researchers measure

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

    Time frame: 24 months

Secondary outcomes

  1. Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer.

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01036633
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
Dec 21, 2009
Start date
Aug 2009
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Mar 22, 2012

Study contacts

Emre Vural, MD
principal investigator · UAMS
Elias Anaissie, MD
principal investigator · UAMS
Gal Shafirstein, PhD
principal investigator · UAMS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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