Lymphedema Clinical Trial
Official title:
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
Verified date | March 2021 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster | The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment | Up to 12 months after treatment | |
Secondary | Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility | The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment | Up to 12 months after treatment | |
Secondary | Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale) | The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment | 12 months after treatment | |
Secondary | Validity of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale) in terms of criteria correlations, sensitivity to change, and clinical feasibility | The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment | 12 months after treatment | |
Secondary | Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival | The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment | 12 months after treatment | |
Secondary | Validity of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival, in terms of concordance correlation, sensitivity to change, and clinical feasibility | The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment | 12 months after treatment |
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