Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Fibrosis; Lymphedema; Oropharyngeal Cancer; Oral Cavity Cancer
• Intervention / Treatment: Other: LEF measures; Procedure: Technical measure; Procedure: Technical measure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: LEF measures; Patient-reported outcome measure; clinician-reported outcome measures; Procedure: Technical measure; Undergo standard CT scan; Other Names: Computed Tomography (CT); Procedure: Technical measure; Undergo standard ultrasound; Other Names: Ultrasonography, Ultrasound (US) Medical Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Jie Deng, Vanderbilt-Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 3, 2015
• First Submitted That Met QC Criteria: April 4, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Fibrosis; Lymphedema; Mouth Neoplasms; Oropharyngeal Neoplasms
• Other Study ID Numbers: VICC SUPP 1529; 1R01DE024982-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No