An Exploratory Study on Optical Assessment of Oral Mucositis
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Purpose
Objectives:
- To assess the tolerability of performing optical coherence tomography and/or optical spectroscopy in patients with acute oral mucositis.
- 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.
- 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 |
- 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 |
Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
Inclusion Criteria:
- Patients greater than 18 years old.
- Patients undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
- Subject must sign an informed consent indicating awareness of the investigational nature of this study.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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 May 19, 2013