A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
Study Details
Study Description
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:
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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.
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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 Design
Arms and Interventions
| 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: Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Other Names:
Procedure: Diagnostic Imaging
Undergo photographs of face and neck
Other Names:
Other: Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Procedure: Modified Barium Swallow
Undergo swallow study
Other Names:
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:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Other: Voice Handicap Index-10
Ancillary studies
Other Names:
|
| 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: Best Practice
Undergo self-manual lymphatic drainage
Other Names:
Other: Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Other Names:
Procedure: Diagnostic Imaging
Undergo photographs of face and neck
Other Names:
Other: Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Procedure: Modified Barium Swallow
Undergo swallow study
Other Names:
Procedure: Nasopharyngeal Laryngoscopy
Undergo Nasolaryngoscopy
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Other: Voice Handicap Index-10
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Compare composite measurements of the face and neck for lymphatic drainage [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 in lymphedema of the head and neck [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.
Secondary Outcome Measures
- Improvements on quality of life (QOL) function [Up to 12 weeks]
Measured by QOL questionnaire and Facial and Neck Composite Measurements Status Scale: PSS-HN
- Improvements on voice function [Up to 12 weeks]
Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
- Improvements on swallowing function [Up to 12 weeks]
Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance
Eligibility Criteria
Criteria
Inclusion Criteria:
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Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
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Cognitive function adequate to understand and execute the elements of the protocol
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Willingness and ability to return to Mayo Clinic for follow-up care per protocol
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Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
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Must demonstrate oropharyngeal competency that would allow some oral intake
Exclusion Criteria:
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Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
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Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
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Acute facial infection
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Active congestive heart failure (CHF) or pulmonary edema
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Symptomatic carotid artery disease or bradycardia
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Increased intracranial pressure
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History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
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50% internal carotid artery (ICA) blockage
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Upper quadrant deep vein thrombosis
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Known esophageal obstruction
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Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
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Women of child-bearing potential
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(Active) pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Lisa Crujido, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-003342
- NCI-2022-06767
- 21-003342
- P30CA015083