Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Lymphedema Clinical Trial

Official title:

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412241
• Other study ID #: VICC SUPP 1529
• Secondary ID: 1R01DE024982-01
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2020

Study information

• Verified date: March 2021
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fibrosis
• Lymphedema
• Mouth Neoplasms
• Oral Cavity Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Other:
• LEF measures
Patient-reported outcome measure; clinician-reported outcome measures

Procedure:
• Technical measure
Undergo standard CT scan
• Technical measure
Undergo standard ultrasound

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Vanderbilt Ingram Cancer Center, Find a Clinical Trial