Trials / Withdrawn

WithdrawnNCT05512767

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

Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population

Status: Withdrawn
Phase: N/A
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Mayo Clinic · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2022-12-01
Primary completion: 2023-08-22
Completion: 2024-08-22
First posted: 2022-08-23
Last updated: 2023-01-06

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT05512767. Inclusion in this directory is not an endorsement.