An Exploratory Study on Optical Assessment of Oral Mucositis

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488332
First received: June 19, 2007
Last updated: July 18, 2012
Last verified: July 2012

June 19, 2007
July 18, 2012
March 2006
July 2010   (final data collection date for primary outcome measure)
Optical assessment of oral mucositis in patients undergoing radiation or chemoradiation for head and neck cancer treatment [ Time Frame: Two sets of oral scans; one at baseline and the second 2 weeks into therapy ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00488332 on ClinicalTrials.gov Archive Site
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An Exploratory Study on Optical Assessment of Oral Mucositis
An Exploratory Study on Optical Assessment of Oral Mucositis

Objectives:

  1. To assess the tolerability of performing optical coherence tomography and/or optical spectroscopy in patients with acute oral mucositis.
  2. To determine the feasibility of obtaining optical coherence tomography images and/or fluorescence excitation emission matrices from normal and affected sites in patients with acute oral mucositis.
  3. To compare optical data obtained with optical coherence tomography and/or spectroscopy with the clinical appearance and scoring of oral mucositis lesions.

Optical coherence tomography (OCT) works similarly to ultrasound but uses infrared light waves rather than sound waves to create high-resolution pictures. This tool has been approved by the Food & Drug Administration (FDA), is used routinely for standard diagnosis of eye conditions, and is now being used to look inside your mouth for tissue changes.

For the OCT procedure, a small probe, about the size of a pencil eraser, will be gently placed against the lining of your mouth and light will be shone through the probe to create pictures of the tissue. The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth. If there are no abnormal-looking areas, researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue, since these are the areas most often affected by the chemotherapy and radiation therapies.

In fluorescence spectroscopy (FS), a small beam of light, shines through a small probe onto the lining of the mouth. A small amount of light will be emitted from the tissue in the form of fluorescence, similar to "glow in the dark" toys . This light is not seen by the eye, but it is detected by the probe and recorded by a computer.

For the FS procedure, a small probe, about the size of a pencil eraser, will be gently placed against the lining of your mouth and light will be shone through the probe. The probe will then collect the fluorescence light signals and they will be recorded on a computer. The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth. If there are no abnormal-looking areas, researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue, since these are the areas most often affected by the chemotherapy and radiation therapies.

If you agree to take part in this study, your mouth will be examined before your treatment begins, and then once a week after that. Every week, you will also be asked how much pain you are having on a scale of 1-10.

Photographs will be taken of the inside of the mouth with a standard camera. You will not be identified in these photographs.

You will be asked to return once a week until you finish all radiation treatments to have all the exams repeated. Most radiation treatments last about 6-8 weeks.

This is an investigational study. About 18 patients will take part in this study. All will be enrolled at M. D. Anderson.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.

  • Head and Neck Cancer
  • Oral Mucositis
  • Procedure: Optical Coherence Tomography
    Before radiation treatment and once a week thereafter.
    Other Name: OCT
  • Procedure: Fluorescence Spectroscopy
    Before radiation treatment and once a week thereafter.
    Other Name: FS
  • Behavioral: Pain Scale Questionnaire
    Administered before the examination, OCT, and FS and immediately afterward.
    Other Name: Survey
OCT + FS + Questionnaire
Optical Coherence Tomography (OCT) + Fluorescence Spectroscopy (FS) and Questionnaire
Interventions:
  • Procedure: Optical Coherence Tomography
  • Procedure: Fluorescence Spectroscopy
  • Behavioral: Pain Scale Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients greater than 18 years old.
  2. Patients undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
  3. Subject must sign an informed consent indicating awareness of the investigational nature of this study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00488332
2005-0872
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP