Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Vanderbilt University Medical Center

Status: Completed

Conditions: Oropharyngeal Cancer; Oral Cavity Cancer; Lymphedema; Fibrosis

Treatments: Procedure: Technical measure; Other: LEF measures

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02412241

VICC SUPP 1529

1R01DE024982-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

LEF Measures

Other group

Description:

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.

Treatment:

Procedure: Technical measure

Other: LEF measures

Procedure: Technical measure