Clinical trial NCT00488332: An Exploratory Study on Optical Assessment of Oral Mucositis
Official title: An Exploratory Study on Optical Assessment of Oral Mucositis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Cancer
Oral Mucositis
Keywords: Head and Neck Cancer
Oral Mucositis
Optical Coherence Tomography
Fluorescence Spectroscopy
Optical Assessment
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-06-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.

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.

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 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.

Primary outcomes:
measure: Optical assessment of oral mucositis in patients undergoing radiation or chemoradiation for head and neck cancer treatment
timeFrame: Two sets of oral scans; one at baseline and the second 2 weeks into therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ann M. Gillenwater, MD
role: PRINCIPAL_INVESTIGATOR
References: