Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/5/2019 |
| Start Date: | June 2015 |
| End Date: | June 2019 |
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.
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.
The goal of this proposed study is to establish a valid, clinically useful measurement
battery for head and neck LEF by achieving these specific aims:
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.
battery for head and neck LEF by achieving these specific aims:
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
2220 Pierce Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Jie Deng
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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