Head and Neck CancerNCT00488332
An Exploratory Study on Optical Assessment of Oral Mucositis
An observational study of Head and Neck Cancer and Oral Mucositis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oral Mucositis
- What is being tested?
- Optical Coherence Tomography, Fluorescence Spectroscopy and Pain Scale Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Being tested
- Optical Coherence Tomography, Fluorescence Spectroscopy, Pain Scale Questionnaire
- Keywords
- Head and Neck Cancer, Oral Mucositis, Optical Coherence Tomography, Fluorescence Spectroscopy, Optical Assessment
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyProcedure or surgery
Also called OCT
Before radiation treatment and once a week thereafter.
Fluorescence SpectroscopyProcedure or surgery
Also called FS
Before radiation treatment and once a week thereafter.
Pain Scale QuestionnaireBehavioural
Also called Survey
Administered before the examination, OCT, and FS and immediately afterward.
| Study group | Role | What they receive |
|---|---|---|
| OCT + FS + Questionnaire | Optical Coherence Tomography (OCT) + Fluorescence Spectroscopy (FS) and Questionnaire Receives: Procedure: Optical Coherence Tomography; Procedure: Fluorescence Spectroscopy; Behavioral: Pain Scale Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical assessment of oral mucositis in patients undergoing radiation or chemoradiation for head and neck cancer treatment
Measured: Two sets of oral scans; one at baseline and the second 2 weeks into therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startMar 2006
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann M. Gillenwater, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488332
- Sponsor's protocol ID
- 2005-0872
- Status last verified
- Jul 2012
- First submitted
- 19 Jun 2007
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on Optical Assessment of Oral Mucositis
- ClinicalTrials.gov ID
- NCT00488332
- Acronym / sponsor ID
- 2005-0872
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Keywords
- Head and Neck Cancer, Oral Mucositis, Optical Coherence Tomography, Fluorescence Spectroscopy, Optical Assessment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT + FS + Questionnaire | – | Procedure: Optical Coherence Tomography, Procedure: Fluorescence Spectroscopy, Behavioral: Pain Scale QuestionnaireOptical Coherence Tomography (OCT) + Fluorescence Spectroscopy (FS) and Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyAlso: OCTBefore radiation treatment and once a week thereafter. | Procedure or surgery | OCT + FS + Questionnaire |
| Fluorescence SpectroscopyAlso: FSBefore radiation treatment and once a week thereafter. | Procedure or surgery | OCT + FS + Questionnaire |
| Pain Scale QuestionnaireAlso: SurveyAdministered before the examination, OCT, and FS and immediately afterward. | Behavioural | OCT + FS + Questionnaire |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M. Gillenwater, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Oral Mucositis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.