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

January 4, 2023 updated by: Mayo Clinic

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
  • Cognitive function adequate to understand and execute the elements of the protocol
  • Willingness and ability to return to Mayo Clinic for follow-up care per protocol
  • Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
  • Must demonstrate oropharyngeal competency that would allow some oral intake

Exclusion Criteria:

  • Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
  • Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
  • Acute facial infection
  • Active congestive heart failure (CHF) or pulmonary edema
  • Symptomatic carotid artery disease or bradycardia
  • Increased intracranial pressure
  • History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
  • > 50% internal carotid artery (ICA) blockage
  • Upper quadrant deep vein thrombosis
  • Known esophageal obstruction
  • Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
  • Women of child-bearing potential
  • (Active) pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (pneumatic therapy, lymphedema management)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Other Names:
  • CAPE-V
  • Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Procedure: Diagnostic Imaging
Undergo photographs of face and neck
Other Names:
  • Medical Imaging
Other: Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Procedure: Modified Barium Swallow
Undergo swallow study
Other Names:
  • MBS
  • VFSS
  • Videofluoroscopic Swallowing 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 Names:
  • Flexi-touch Plus System
Other: Voice Handicap Index-10
Ancillary studies
Other Names:
  • VHI-10
  • Voice Handicap Index-10 (VHI-10)
Active Comparator: Group II (standard of care, lymphedema management)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Other Names:
  • CAPE-V
  • Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Procedure: Diagnostic Imaging
Undergo photographs of face and neck
Other Names:
  • Medical Imaging
Other: Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Procedure: Modified Barium Swallow
Undergo swallow study
Other Names:
  • MBS
  • VFSS
  • Videofluoroscopic Swallowing Study
Procedure: Nasopharyngeal Laryngoscopy
Undergo Nasolaryngoscopy
Other: Voice Handicap Index-10
Ancillary studies
Other Names:
  • VHI-10
  • Voice Handicap Index-10 (VHI-10)
Other: Best Practice
Undergo self-manual lymphatic drainage
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare composite measurements of the face and neck for lymphatic drainage
Time Frame: Change from baseline and up to 12 weeks
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.
Change from baseline and up to 12 weeks
Change in lymphedema of the head and neck
Time Frame: Up to 12 weeks
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.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements on quality of life (QOL) function
Time Frame: Up to 12 weeks

Measured by QOL questionnaire and Facial and Neck Composite Measurements

Status Scale:

PSS-HN
Up to 12 weeks
Improvements on voice function
Time Frame: Up to 12 weeks
Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
Up to 12 weeks
Improvements on swallowing function
Time Frame: Up to 12 weeks
Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Lisa Crujido, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

August 22, 2023

Study Completion (Anticipated)

August 22, 2024

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-003342
  • NCI-2022-06767 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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