A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

• ClinicalTrials.gov Identifier: NCT04797390
• Recruitment Status: Recruiting
• First Posted: March 15, 2021
• Last Update Posted: January 25, 2022
• Sponsor: Tactile Medical
• Collaborator: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Tactile Medical

Study Description

Brief Summary:

To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

Condition or disease	Intervention/treatment	Phase
Lymphedema; Lymphedema of Face; Lymphedema, Secondary; Lymphedema Due to Radiation; Lymphedema; Surgical	Device: Advanced Pneumatic Compression Device (APCD); Other: Usual Care	Not Applicable

Detailed Description:

Aim 1:

To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on anatomical measures of internal and external LEF. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term reduction in anatomical measures of LEF.

Aim 2:

To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on patient reported biopsychosocial outcome measures impacted by LEF. Outcome measures will include: 1) symptom burden, 2) symptom burden and functional impairment, 3) quality of life (QOL), 4) work and activity, 5) perceived self-management capacity, 6) body image, and 7) diet modifications. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term improvement in patient reported biopsychosocial outcomes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema
• Actual Study Start Date: September 23, 2021
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Advanced Pneumatic Compression Device (APCD); Daily self-administered treatment with the Flexitouch® Plus system (FT)	Device: Advanced Pneumatic Compression Device (APCD); Once daily treatment with Flexitouch Plus.; Other Names: Flexitouch; Flexitouch Plus
Active Comparator: Usual Care; Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist	Other: Usual Care; Usual care consists of a two-phase CDT. Phase 1 includes consultation with a lymphedema therapist, patient education, MLD, compression garments or bandages, skin care techniques, and a program of exercises and postural recommendations. Phase 2 consists of ongoing self-care, where patients conduct a life-long program of disease management that mimics the program in phase 1.; Other Names: Complete Decongestive Therapy (CDT); Manual Lymphatic Drainage (MLD)

Outcome Measures

Primary Outcome Measures :

1. Reduction in Swelling/Inflammation - Endoscopy [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   The change in percent of sites with visible swelling and inflammation as assessed via endoscopy (using Modified Patterson Scale). The range for each anatomical structure includes 1-4: Normal, Mild, Moderate, and Severe. A lower score means a better outcome. A greater negative value indicates a greater reduction in swelling. Total score range: 0-100%
2. Reduction in Swelling/Imaging - CT [ Time Frame: Changes between Baseline, 2 months, 6 months ]
   The changes in fat stranding, epiglottic thickness, and prevertebral soft tissue (PVST) using the CT Lymphedema and Fibrosis Assessment Tool (CT-LEFAT). The range for fat stranding includes 0-2: Normal, Mild Changes, Advanced Changes. A lower score means a better outcome. Epiglottis and PVST are measured in mm. A lower measurement means a better outcome.
3. Reduction in Swelling/Inflammation - Grading of External Lymphedema [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   The presence of swelling and inflammation as assessed through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Assessment criteria (HNLEF). A total of 9 sites are evaluated for the presence of lymphedema and graded from 1 (mild) to 3 (severe) at each site. The number of sites ranged from 0-9 with a total severity score ranging from 0-27. A lower score indicates a better outcome. A greater negative value indicates a greater reduction in swelling.
4. Reduction in Swelling/Inflammation - Digital Photography [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   The presence of swelling and inflammation are assessed by digital photography. A lower value means a better outcome. A greater negative value indicates a greater reduction in swelling. Three views are scored each with 30 grids. The percentage of views with visible swelling was determined. The score ranges from 0-100%.
5. Symptom Burden - Lymphedema Symptom Intensity and Distress Survey [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN) assesses the measurement characteristics of a symptom burden for participants with head and neck lymphedema. Each symptom is rated on intensity and distress using a 5-point scale. A maximum response for any symptom within a given cluster will be used for the analysis. The total score ranged from 0-10. The values represent a change from baseline. A lower score means a better outcome.
6. Symptom Burden and Functional Impairment - Vanderbilt Head and Neck Symptom Survey [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey (VHNSS plus GSS) assesses symptom burden and functional impairment. Values represent a median score change from baseline. Score range: 0-10. A lower score indicates a better outcome. A more negative value indicates a greater change from baseline.
7. Quality of Life - Linear Analog Self-Assessment [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   Quality of life is assessed using the Linear Analog Self-Assessment. The total score for the assessment ranges from 0-50. Each category represents a change in score from the baseline visit which ranged from positive 4 to negative 4. A positive change indicates an improvement.
8. Work and Activity - Work Productivity and Activity Impairment Questionnaire [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   Work Productivity and Activity Impairment Questionnaire (WPAIQ) PRO assessment asks questions about work and activity impairment due to lymphedema and other health problems. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. Total score range: 0-100%
9. Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS) [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
   The 8-item Perceived Medical Condition Self-Management Scale (PMCSMS) is intended to measure patients' belief that they are capable of carrying out the self-management behaviors required by their medical condition. The scale is composed of four positively worded items and four negatively worded items, each rated on a five-point Likert scale (1=Strongly Disagree to 5=Strongly Agree). Negatively worded items are reversed scored, yielding a total score ranging from 8 to 40, with a higher score indicating stronger belief of perceived self-management competence.
10. Body image - Body Image Quality of Life Inventory (BIQLI) [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
    Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7 point scale ranging from -3 (very negative) to +3 (very positive). Score range: -57 to 57. A higher score indicates a better outcome.
11. Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) [ Time Frame: Changes between Baseline, 2 months, 4 months, 6 months ]
    Diet modifications will be assessed using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). The ASA24 is a tool from National Cancer Institute (NCI) that enables multiple automatically coded self-administered 24-hour recalls and food records. Changes in total caloric intake, fat, carbohydrate, fiber, sugars, and protein will be evaluated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
3. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
4. A diagnosis of either internal or external head and neck lymphedema
5. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
6. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation
7. Must be able to speak and understand English

Exclusion Criteria:

1. Previous APCD or Usual Care treatment for HNC LEF
2. Acute facial infection (e.g., facial or parotid gland abscess)
3. Known carotid sinus hypersensitivity syndrome
4. Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
5. Internal jugular venous thrombosis (within 3 months)
6. Patient is pregnant or trying to become pregnant

Contacts and Locations

Contacts

Contact: Clinical Research Department; 1-866-494-4281; clinicalresearch@tactilemedical.com

Contact: Heather Smith; 612-800-5539; hsmith@tactilemedical.com

Locations

United States, Alabama

University of Alabama; Recruiting

Birmingham, Alabama, United States, 35924

Contact: Amy Cleverdon aminchin@uabmc.edu

Principal Investigator: Christopher Willey, MD, PhD

Sub-Investigator: Anthony Morlandt, MD, DDS

United States, Illinois

Rush University Medical Center; Not yet recruiting

Chicago, Illinois, United States, 60612

Contact: Mahendrakumar Shah 312-942-9967 mahendrakumar_shah@rush.edu

Principal Investigator: Mihir Bhayani, M.D.

United States, Kentucky

University of Louisville; Not yet recruiting

Louisville, Kentucky, United States, 40202

Contact: Neal Dunlap, MD

Principal Investigator: Neal Dunlap, MD

Sub-Investigator: Jeffrey Bumpous, MD

United States, Maryland

Johns Hopkins University; Not yet recruiting

Baltimore, Maryland, United States, 21205

Contact: Harry Quon

Principal Investigator: Harry Quon, MD

United States, Michigan

University of Michigan; Not yet recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Cancer Answer Line 800-865-1125

Principal Investigator: Frank Worden, MD

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Contact: Melanie Copeland 615-587-2166 melanie.e.copeland@vumc.org

Principal Investigator: Barbara Murphy, MD

Sponsors and Collaborators

Tactile Medical

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Barbara Murphy, MD; Vanderbilt University Medical Center
• Principal Investigator: Sheila Ridner, RN, PhD; Vanderbilt University

More Information

• Responsible Party: Tactile Medical
• ClinicalTrials.gov Identifier: NCT04797390
• Other Study ID Numbers: 8030
• First Posted: March 15, 2021
• Last Update Posted: January 25, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tactile Medical:

Head and Neck Lymphedema

Additional relevant MeSH terms:

Lymphedema; Lymphatic Diseases