Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
Completed · Not applicable
Conditions studied: Oral Cavity Cancer, Oropharyngeal Cancer, Lymphedema, Fibrosis
In brief
This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients. 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.
Key facts
- Study ID
- NCT02412241
- Run by
- Vanderbilt-Ingram Cancer Center
- People needed
- 118
- Starts
- 2015-06-01
- Expected to finish
- 2020-08-01
- Last updated by the study team
- 2021-03-03
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx
- 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.
You may not qualify if…
- have medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
- are unwilling to undergo routine follow-up
- have recurrent cancer
- have any other active cancer.
Where it is running
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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