Clinical trial NCT02412241: Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
Official title: Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cavity Cancer
Oropharyngeal Cancer
Lymphedema
Fibrosis
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2015-04-09
Enrollment: 118
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
timeFrame: Up to 12 months after treatment
Secondary outcomes:
measure: Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility
timeFrame: Up to 12 months after treatment
measure: Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)
timeFrame: 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
timeFrame: 12 months after treatment
measure: Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival
timeFrame: 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
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jie Deng
role: PRINCIPAL_INVESTIGATOR
References: