Clinical Trials /

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

NCT02412241

Description:

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.

Related Conditions:
  • Malignant Oral Cavity Neoplasm
  • Oropharyngeal Carcinoma
Recruiting Status:

Completed

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02412241

Trial Eligibility

Document

Title

  • Brief Title: Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
  • Official Title: Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: VICC SUPP 1529
  • SECONDARY ID: 1R01DE024982-01
  • NCT ID: NCT02412241

Conditions

  • Oral Cavity Cancer
  • Oropharyngeal Cancer
  • Lymphedema
  • Fibrosis

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
LEF MeasuresOtherPATIENT-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.

    Eligibility Criteria

            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.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:21 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Measure: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
    Safety Issue:
    Description:The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment
    Measure:Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)
    Time Frame:12 months after treatment
    Safety Issue:
    Description:The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment
    Measure: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
    Safety Issue:
    Description:The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment
    Measure:Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival
    Time Frame:12 months after treatment
    Safety Issue:
    Description:The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment
    Measure: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
    Safety Issue:
    Description:The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Completed
    Lead Sponsor:Vanderbilt-Ingram Cancer Center

    Last Updated

    March 3, 2021