Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
NCT ID: NCT02412241
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
118 participants
INTERVENTIONAL
2015-06-30
2020-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
NCT00042926
The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer
NCT05164445
Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
NCT01992068
Study of Biomarker From Blood and Tissue of Head and Neck Carcinoma
NCT01171235
Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.
NCT01456429
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim 1: To determine the reliability and validity of the patient-reported outcome measure (LSIDS-H\&N) for assessing LEF-related symptoms in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 2: To determine the reliability and validity of the clinician-reported outcome measures (HN-LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 3: To determine the reliability and validity of imaging techniques (CT scan and ultrasonography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LEF Measures
PATIENT-REPORTED OUTCOME MEASURE: Validity of LSIDS-H\&N will be assessed using 6 forms (e.g., Vanderbilt Head and Neck Symptom Survey (v2.0); Neck Disability Index; and Hospital Anxiety and Depression Scale).
CLINICIAN-REPORTED OUTCOME MEASURES: External LEF will be assessed using HN-LEF Grading Criteria, CTCAE (v4.03), and digital photos of the head and neck. Internal LEF will be scored using Modified Patterson Scale through an endoscopic exam. Both external/internal measures are re-assessed for intrarater and interrater reliability.
OBJECTIVE/TECHNICAL MEASURES: Patients undergo CT scans and ultrasound exams with results re-scored for intrarater and interrater reliability.
LEF measures
Patient-reported outcome measure; clinician-reported outcome measures
Technical measure
Undergo standard CT scan
Technical measure
Undergo standard ultrasound
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LEF measures
Patient-reported outcome measure; clinician-reported outcome measures
Technical measure
Undergo standard CT scan
Technical measure
Undergo standard ultrasound
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* tumor stage II or greater
* age ≥ 21 years old
* willing and able to undergo study assessment
* able to speak and read English and understand Informed Consent.
Exclusion Criteria
* are unwilling to undergo routine follow-up
* have recurrent cancer
* have any other active cancer.
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jie Deng
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jie Deng
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Vanderbilt Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VICC SUPP 1529
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.