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Withdrawn NA INTERVENTIONAL NCT05512767

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

PRIMARY OBJECTIVES: I. Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD. II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I: Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline. GROUP II: Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.

Interventions

Name: Best Practice
Type: OTHER
Description: Undergo self-manual lymphatic drainage
Name: Consensus Auditory-Perceptual Evaluation of Voice
Type: OTHER
Description: Ancillary studies
Name: Diagnostic Imaging
Type: PROCEDURE
Description: Undergo photographs of face and neck
Name: Lymphedema Management
Type: OTHER
Description: Undergo skilled lymphedema treatment by a therapist
Name: Modified Barium Swallow
Type: PROCEDURE
Description: Undergo swallow study
Name: Nasopharyngeal Laryngoscopy
Type: PROCEDURE
Description: Undergo Nasolaryngoscopy
Name: Pneumatic Compression Therapy
Type: DEVICE
Description: 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.
Name: Quality-of-Life Assessment
Type: OTHER
Description: Ancillary studies
Name: Questionnaire Administration
Type: OTHER
Description: Ancillary studies
Name: Voice Handicap Index-10
Type: OTHER
Description: Ancillary studies

Primary Outcomes

Measure: Compare composite measurements of the face and neck for lymphatic drainage
TimeFrame: Change from baseline and up to 12 weeks
Description: Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.
Measure: Change in lymphedema of the head and neck
TimeFrame: Up to 12 weeks
Description: A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.

Trial Information

NCT ID

NCT05512767

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Mayo Clinic

Last Updated

December 15, 2025