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Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

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ClinicalTrials.gov Identifier: NCT02412241
Recruitment Status : Recruiting
First Posted : April 9, 2015
Last Update Posted : January 25, 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

April 3, 2015
April 9, 2015
January 25, 2018
June 2015
February 2019   (Final data collection date for primary outcome 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 ]
The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment
Same as current
Complete list of historical versions of study NCT02412241 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Oral Cavity Cancer
  • Oropharyngeal Cancer
  • Lymphedema
  • Fibrosis
  • 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
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.

Interventions:
  • Other: LEF measures
  • Procedure: Technical measure
  • Procedure: Technical measure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
February 2019
February 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
 
NCT02412241
VICC SUPP 1529
1R01DE024982-01 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Jie Deng, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
  • National Cancer Institute (NCI)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Jie Deng Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP