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An Exploratory Study on Optical Assessment of Oral Mucositis


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Oral Mucositis

Thank you

Trial Information

An Exploratory Study on Optical Assessment of Oral Mucositis


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Optical assessment of oral mucositis in patients undergoing radiation or chemoradiation for head and neck cancer treatment

Outcome Time Frame:

Two sets of oral scans; one at baseline and the second 2 weeks into therapy

Safety Issue:

No

Principal Investigator

Ann M. Gillenwater, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0872

NCT ID:

NCT00488332

Start Date:

March 2006

Completion Date:

July 2010

Related Keywords:

  • Head and Neck Cancer
  • Oral Mucositis
  • Head and Neck Cancer
  • Oral Mucositis
  • Optical Coherence Tomography
  • Fluorescence Spectroscopy
  • Optical Assessment
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030