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
  Purpose

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 Intervention
Head and Neck Cancer
Oral Mucositis
Procedure: Optical Coherence Tomography
Procedure: Fluorescence Spectroscopy
Behavioral: Pain Scale Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Exploratory Study on Optical Assessment of Oral Mucositis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: March 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488332     History of Changes
Other Study ID Numbers: 2005-0872
Study First Received: June 19, 2007
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

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
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014