A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
NCT ID: NCT05512767
Last Updated: 2023-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-12-01
2024-08-22
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Diagnostic Imaging
Undergo photographs of face and neck
Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Modified Barium Swallow
Undergo swallow study
Nasopharyngeal Laryngoscopy
Undergo Nasolaryngoscopy
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.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Voice Handicap Index-10
Ancillary studies
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.
Best Practice
Undergo self-manual lymphatic drainage
Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Diagnostic Imaging
Undergo photographs of face and neck
Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Modified Barium Swallow
Undergo swallow study
Nasopharyngeal Laryngoscopy
Undergo Nasolaryngoscopy
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Voice Handicap Index-10
Ancillary studies
Interventions
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Best Practice
Undergo self-manual lymphatic drainage
Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies
Diagnostic Imaging
Undergo photographs of face and neck
Lymphedema Management
Undergo skilled lymphedema treatment by a therapist
Modified Barium Swallow
Undergo swallow study
Nasopharyngeal Laryngoscopy
Undergo Nasolaryngoscopy
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.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Voice Handicap Index-10
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Lisa Crujido
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Other Identifiers
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NCI-2022-06767
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-003342
Identifier Type: -
Identifier Source: org_study_id
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