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

Summary

This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.

Conditions

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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Lisa Crujido · Mayo Clinic

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2023-08-22

Completion

2024-08-22

FDA Device

Yes