Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

NCT02412241 | Completed DMC

• 2 other identifiers: VICC SUPP 15291R01DE024982-01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Cavity Cancer; Oropharyngeal Cancer; Lymphedema; Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility

  Up to 12 months after treatment

• Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)

  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

  12 months after treatment

• Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival

  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

  12 months after treatment

Study Arms (1)

LEF Measures

OTHER

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; Procedure: Technical measure

Interventions

LEF measures OTHER

Patient-reported outcome measure; clinician-reported outcome measures

LEF Measures

Technical measure PROCEDURE

Undergo standard CT scan

Also known as: Computed Tomography (CT)

LEF Measures

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms; Lymphedema; Fibrosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Jie Deng

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 9, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)