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

Primary Purpose

Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Best Practice
Consensus Auditory-Perceptual Evaluation of Voice
Diagnostic Imaging
Lymphedema Management
Modified Barium Swallow
Nasopharyngeal Laryngoscopy
Pneumatic Compression Therapy
Quality-of-Life Assessment
Questionnaire Administration
Voice Handicap Index-10
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group I (pneumatic therapy, lymphedema management)

    Group II (standard of care, lymphedema management)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Compare composite measurements of the face and neck for lymphatic drainage
    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
    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
    Measured by QOL questionnaire and Facial and Neck Composite Measurements Status Scale: PSS-HN
    Improvements on voice function
    Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
    Improvements on swallowing function
    Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance

    Full Information

    First Posted
    August 17, 2022
    Last Updated
    January 4, 2023
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05512767
    Brief Title
    A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
    Official Title
    Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI retired and study not moving forward
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    August 22, 2023 (Anticipated)
    Study Completion Date
    August 22, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. 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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma, Head and Neck Carcinoma, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I (pneumatic therapy, lymphedema management)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group II (standard of care, lymphedema management)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Best Practice
    Other Intervention Name(s)
    standard of care, standard therapy
    Intervention Description
    Undergo self-manual lymphatic drainage
    Intervention Type
    Other
    Intervention Name(s)
    Consensus Auditory-Perceptual Evaluation of Voice
    Other Intervention Name(s)
    CAPE-V, Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
    Intervention Description
    Ancillary studies
    Intervention Type
    Procedure
    Intervention Name(s)
    Diagnostic Imaging
    Other Intervention Name(s)
    Medical Imaging
    Intervention Description
    Undergo photographs of face and neck
    Intervention Type
    Other
    Intervention Name(s)
    Lymphedema Management
    Intervention Description
    Undergo skilled lymphedema treatment by a therapist
    Intervention Type
    Procedure
    Intervention Name(s)
    Modified Barium Swallow
    Other Intervention Name(s)
    MBS, VFSS, Videofluoroscopic Swallowing Study
    Intervention Description
    Undergo swallow study
    Intervention Type
    Procedure
    Intervention Name(s)
    Nasopharyngeal Laryngoscopy
    Intervention Description
    Undergo Nasolaryngoscopy
    Intervention Type
    Device
    Intervention Name(s)
    Pneumatic Compression Therapy
    Other Intervention Name(s)
    Flexi-touch Plus System
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Quality-of-Life Assessment
    Other Intervention Name(s)
    Quality of Life Assessment
    Intervention Description
    Ancillary studies
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Intervention Type
    Other
    Intervention Name(s)
    Voice Handicap Index-10
    Other Intervention Name(s)
    VHI-10, Voice Handicap Index-10 (VHI-10)
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Compare composite measurements of the face and neck for lymphatic drainage
    Description
    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.
    Time Frame
    Change from baseline and up to 12 weeks
    Title
    Change in lymphedema of the head and neck
    Description
    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.
    Time Frame
    Up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Improvements on quality of life (QOL) function
    Description
    Measured by QOL questionnaire and Facial and Neck Composite Measurements Status Scale: PSS-HN
    Time Frame
    Up to 12 weeks
    Title
    Improvements on voice function
    Description
    Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
    Time Frame
    Up to 12 weeks
    Title
    Improvements on swallowing function
    Description
    Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance
    Time Frame
    Up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa Crujido
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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