NCT05512767 - A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation | Biotech Hunter

Timeline

Start Date

December 1, 2022

Primary Completion Date

August 22, 2023

Study Completion Date

August 22, 2024

Conditions

Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal CarcinomaClinical Stage III HPV-Mediated (p16-pos) Oropharyngeal CarcinomaClinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal CarcinomaHead and Neck CarcinomaStage II Hypopharyngeal Carcinoma AJCC v8Stage II Laryngeal Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

OTHER

Best Practice

Undergo self-manual lymphatic drainage

OTHER

Consensus Auditory-Perceptual Evaluation of Voice

Ancillary studies

PROCEDURE

Diagnostic Imaging

Undergo photographs of face and neck

OTHER

Lymphedema Management

Undergo skilled lymphedema treatment by a therapist

PROCEDURE

Modified Barium Swallow

Undergo swallow study

PROCEDURE

Nasopharyngeal Laryngoscopy

Undergo Nasolaryngoscopy

DEVICE

Pneumatic Compression Therapy

Undergo compression therapy - Flexitouch Plus System is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides systematic and sequential pressure changes to move fluid to intact lymphatic chains.

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Voice Handicap Index-10

Ancillary studies