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Trial record 8 of 2104 for:    Oral Cancer | NIH

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

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ClinicalTrials.gov Identifier: NCT02412241
Recruitment Status : Active, not recruiting
First Posted : April 9, 2015
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Jie Deng, Vanderbilt-Ingram Cancer Center

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.


Condition or disease Intervention/treatment Phase
Oral Cavity Cancer Oropharyngeal Cancer Lymphedema Fibrosis Other: LEF measures Procedure: Technical measure Not Applicable

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  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
Study Start Date : June 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
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 Name: Computed Tomography (CT)

Procedure: Technical measure
Undergo standard ultrasound
Other Name: Ultrasonography, Ultrasound (US) Medical Ultrasound




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412241


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Jie Deng Vanderbilt-Ingram Cancer Center

Additional Information:
Responsible Party: Jie Deng, Assistant Professor, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02412241     History of Changes
Other Study ID Numbers: VICC SUPP 1529
1R01DE024982-01 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Fibrosis
Lymphedema
Pathologic Processes
Lymphatic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases