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

Not Applicable

Withdrawn

• Conditions: Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma; Head and Neck Carcinoma; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage IV Lip and Oral Cavity Cancer AJCC v8; Stage II Lip and Oral Cavity Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage II Laryngeal Cancer AJCC v8; Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma; Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma
• Interventions: Other: Consensus Auditory-Perceptual Evaluation of Voice; Other: Best Practice; Procedure: Diagnostic Imaging; Other: Lymphedema Management; Procedure: Modified Barium Swallow; Procedure: Nasopharyngeal Laryngoscopy; Device: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Voice Handicap Index-10

• Registration Number: NCT05512767
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Study Start: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06
• Primary Completion: 2023-08-22
• Study Completion: 2024-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group II (standard of care, lymphedema management)	Diagnostic Imaging	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.
Group I (pneumatic therapy, lymphedema management)	Diagnostic Imaging	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 I (pneumatic therapy, lymphedema management)	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.
Group I (pneumatic therapy, lymphedema management)	Voice Handicap Index-10	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 I (pneumatic therapy, lymphedema management)	Consensus Auditory-Perceptual Evaluation of Voice	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 I (pneumatic therapy, lymphedema management)	Modified Barium Swallow	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 I (pneumatic therapy, lymphedema management)	Nasopharyngeal Laryngoscopy	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 I (pneumatic therapy, lymphedema management)	Quality-of-Life Assessment	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 I (pneumatic therapy, lymphedema management)	Questionnaire Administration	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 (standard of care, lymphedema management)	Quality-of-Life Assessment	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.
Group II (standard of care, lymphedema management)	Voice Handicap Index-10	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.
Group II (standard of care, lymphedema management)	Consensus Auditory-Perceptual Evaluation of Voice	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.
Group I (pneumatic therapy, lymphedema management)	Pneumatic Compression Therapy	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 (standard of care, lymphedema management)	Best Practice	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.
Group II (standard of care, lymphedema management)	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.
Group II (standard of care, lymphedema management)	Modified Barium Swallow	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.
Group II (standard of care, lymphedema management)	Nasopharyngeal Laryngoscopy	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.
Group II (standard of care, lymphedema management)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
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

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