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NCT Number: NCT02412241

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.

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Key information

Conditions

Oral Cavity Cancer Fibrosis Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEF measures

Other

Patient-reported outcome measure; clinician-reported outcome measures

Technical measure

Procedure

Undergo standard CT scan

Other names: Computed Tomography (CT)

Primary outcomes

  1. Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster

    Time frame: Up to 12 months after treatment

    The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment

Secondary outcomes

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

    Time frame: Up to 12 months after treatment

    The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment

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

    Time frame: 12 months after treatment

    The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment

  3. 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

    Time frame: 12 months after treatment

    The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment

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

    Time frame: 12 months after treatment

    The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment

  5. 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

    Time frame: 12 months after treatment

    The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2015
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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