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An Exploratory Study on Optical Assessment of Oral Mucositis

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ClinicalTrials.gov Identifier: NCT00488332
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : June 20, 2007
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Oral Mucositis Procedure: Optical Coherence Tomography Procedure: Fluorescence Spectroscopy Behavioral: Pain Scale Questionnaire

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Exploratory Study on Optical Assessment of Oral Mucositis
Study Start Date : March 2006
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
OCT + FS + Questionnaire
Optical Coherence Tomography (OCT) + Fluorescence Spectroscopy (FS) and Questionnaire
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488332


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488332     History of Changes
Other Study ID Numbers: 2005-0872
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Oral Mucositis
Optical Coherence Tomography
Fluorescence Spectroscopy
Optical Assessment

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases