Establishing Lymphedema & Fibrosis Measures in Oral Cancer Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02412241
Study type	Interventional
Source	Vanderbilt-Ingram Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	June 2015
Completion date	August 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05507346` - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema	N/A
Completed	`NCT06067880` - Surgical Intervention and Lymphatic Diseases.
Active, not recruiting	`NCT04797390` - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema	N/A
Completed	`NCT02676752` - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed	`NCT02506530` - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema	N/A
Completed	`NCT06323200` - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
Completed	`NCT02253186` - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema	N/A
Terminated	`NCT02020837` - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema	Early Phase 1
Recruiting	`NCT01318785` - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications	Phase 2
Enrolling by invitation	`NCT02375165` - Biomarkers for the Detection of Lymphatic Insufficiency
Completed	`NCT02308488` - Study of Prone Accelerated Breast And Nodal IMRT	N/A
Completed	`NCT00852930` - Low Level Laser Treatment and Breast Cancer Related Lymphedema	Phase 4
Completed	`NCT01112189` - Use of Stem Cells in Lymphedema Post Mastectomy	Phase 1/Phase 2
Completed	`NCT00743314` - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer	Early Phase 1
Recruiting	`NCT06237907` - Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Terminated	`NCT01580800` - National Breast Cancer and Lymphedema Registry
Suspended	`NCT05366699` - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy	N/A
Completed	`NCT06249360` - Lymphatic System Reflux After Lymphatic Operation
Completed	`NCT06220903` - The Effect of Complex Decongestive Therapy in Patients With Lymphedema	N/A
Terminated	`NCT02923037` - Hatha Yoga in Breast Cancer Survivors	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms