An Exploratory Study on Optical Assessment of Oral Mucositis

NCT00488332 | Terminated

• 1 other identifier: 2005-0872
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.To assess the tolerability of performing optical coherence tomography and/or optical spectroscopy in patients with acute oral mucositis.
2. 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. 3.To compare optical data obtained with optical coherence tomography and/or spectroscopy with the clinical appearance and scoring of oral mucositis lesions.

Conditions

Head and Neck Cancer; Oral Mucositis

Keywords

Head and Neck Cancer; Oral Mucositis; Optical Coherence Tomography; Fluorescence Spectroscopy; Optical Assessment

Outcome Measures

Primary Outcomes (1)

• Optical assessment of oral mucositis in patients undergoing radiation or chemoradiation for head and neck cancer treatment

  Two sets of oral scans; one at baseline and the second 2 weeks into therapy

Study Arms (1)

OCT + FS + Questionnaire

Optical Coherence Tomography (OCT) + Fluorescence Spectroscopy (FS) and Questionnaire

Procedure: Optical Coherence Tomography; Procedure: Fluorescence Spectroscopy; Behavioral: Pain Scale Questionnaire

Interventions

Optical Coherence Tomography PROCEDURE

Before radiation treatment and once a week thereafter.

Also known as: OCT

OCT + FS + Questionnaire

Fluorescence Spectroscopy PROCEDURE

Before radiation treatment and once a week thereafter.

Also known as: FS

OCT + FS + Questionnaire

Pain Scale Questionnaire BEHAVIORAL

Administered before the examination, OCT, and FS and immediately afterward.

Also known as: Survey

OCT + FS + Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals, minimally 18 years old, undergoing radiation therapy or chemoradiotherapy for head and neck cancer treatment.

You may qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Interventions

Tomography, Optical Coherence; Spectrometry, Fluorescence; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Spectrum Analysis; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ann M. Gillenwater, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: March 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

US (1)