LymphedemaNCT04797390

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

A study testing Advanced Pneumatic Compression Device (APCD) in people with Lymphedema and Lymphedema of Face, run by Tactile Medical at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphedema, Lymphedema of Face, Lymphedema, Secondary
What is being tested?: Advanced Pneumatic Compression Device (APCD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 10 sitesUnited States
Study dates: 23 Sep 2021to 3 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Previous APCD or Usual Care treatment for HNC LEF
Acute facial infection (e.g., facial or parotid gland abscess)
Known carotid sinus hypersensitivity syndrome
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)
Internal jugular venous thrombosis (within 3 months)
Patient is pregnant or trying to become pregnant

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama
Birmingham, Alabama, 35924
Rush University Medical Center
Chicago, Illinois, 60612
Karmanos Cancer Institute
Detroit, Michigan, 48201
Advanced Head & Neck Rehabilitation Center of Texas
Fort Worth, Texas, 76104
University of Louisville
Louisville, Kentucky, 40202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Richmond University Medical Center
Staten Island, New York, 10310
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema

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.

Read the 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.

Conditions: Lymphedema, Lymphedema of Face, Lymphedema, Secondary, Lymphedema Due to Radiation, Lymphedema; Surgical
Being tested: Advanced Pneumatic Compression Device (APCD), Usual Care
Keywords: Head and Neck Lymphedema
Medical subject headings: Lymphedema, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Advanced Pneumatic Compression Device (APCD)Device
Also called Flexitouch, Flexitouch Plus
Once daily treatment with Flexitouch Plus.
Usual CareOther
Also called Complete Decongestive Therapy (CDT), Manual Lymphatic Drainage (MLD)
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.

Study groups in NCT04797390
Study group	Role	What they receive
Advanced Pneumatic Compression Device (APCD)	Active comparator	Daily self-administered treatment with the Flexitouch® Plus system (FT) Receives: Device: Advanced Pneumatic Compression Device (APCD)
Usual Care	Active comparator	Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Internal Lymphedema - Endoscopy
The change in average site score from baseline assessed via endoscopy using the Modified Patterson Scale. The range for each site was 0-3: Normal, Mild, Moderate, Severe. A lower score means a better outcome.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Internal Lymphedema - CT Imaging
The changes in fat stranding 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.
Measured: Change from Baseline at 2 months, 6 months
Internal Lymphedema - CT Imaging
The changes in epiglottic thickness, and prevertebral soft tissue (PVST) using the CT Lymphedema and Fibrosis Assessment Tool (CT-LEFAT). Epiglottis and PVST are measured in mm. A lower measurement means a better outcome.
Measured: Change from Baseline at 2 months, 6 months
External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading
The presence of swelling and inflammation as assessed through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Grading criteria (HN-LEFG). 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.
Measured: Change from Baseline at 2 months, 4 months, 6 months
External Lymphedema - Digital Photography
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%.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey
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 (1-Slight to 5-Severe), then added together. The values represent the mean score change from baseline. Score range: 0-10 (0 = symptom not present). A lower score means a better outcome.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Physical Function - Vanderbilt Head and Neck Symptom Survey
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.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Quality of Life - Linear Analog Self-Assessment
Quality of life is assessed using the Linear Analog Self-Assessment. The overall well-being score ranges from 0-10 (0-As bad as it can be to 10-As good as it can be). The value represents the change from baseline. A positive change indicates an improvement.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Work and Activity - Work Productivity and Activity Impairment Questionnaire
Work Productivity and Activity Impairment Questionnaire (WPAIQ) PRO assessment asks questions about work and activity impairment due to lymphedema and other health problems. The values represent the difference from baseline percentage. A greater negative number indicates a greater reduction in impairment. Total score range: 0-100%
Measured: Change from Baseline at 2 months, 4 months, 6 months
Perceived Self-management Capacity - Perceived Medical Condition Self-Management Scale
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.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Body Image - Body Image Quality of Life Inventory
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. The values represent the change from baseline. A higher score indicates a better outcome.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool
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 will be evaluated.
Measured: Change from Baseline at 2 months, 4 months, 6 months
Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool
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 fat, carbohydrate, fiber, sugars, and protein will be evaluated.
Measured: Change from Baseline at 2 months, 4 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 20213 Dec 2024

First posted15 Mar 2021
Study start23 Sep 2021
Primary completion3 Dec 2024
Study completion3 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LymphedemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04797390
Sponsor's protocol ID: 8030
Status last verified: Feb 2026
First submitted: 5 Mar 2021
Last updated: 2 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Murphy BA, Smith DK, Kline-Quiroz CM, Jensen KM, Sukari AW, Bhayani MK, Mehta V, Quon H, Shah JL, Willey CD, Dunlap NE, Lee HK, Aulino JM, Ridner SH. Short-Term Outcomes of Advanced Pneumatic Compression Device Versus Usual Care Therapy for Head and Neck Cancer-Related Lymphedema: A Multi-Site Randomized Clinical Trial. Head Neck. 2026 Apr;48(4):1077-1087. doi: 10.1002/hed.70155. Epub 2026 Jan 23.
PubMed 41574713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema
ClinicalTrials.gov ID: NCT04797390
Acronym / sponsor ID: 8030
Conditions: Lymphedema, Lymphedema of Face, Lymphedema, Secondary, Lymphedema Due to Radiation, Lymphedema; Surgical
Keywords: Head and Neck Lymphedema
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Tactile MedicalIndustry (pharma, biotech, devices)
Collaborators: Vanderbilt University Medical Center
Study start: 23 Sep 2021 (actual)
Primary completion: 3 Dec 2024 (actual)
Study completion: 3 Dec 2024 (actual)
First posted: 15 Mar 2021 (actual)
Results: Posted 2 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Aim 1:

Aim 2:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Advanced Pneumatic Compression Device (APCD)	Active comparator	Device: Advanced Pneumatic Compression Device (APCD)Daily self-administered treatment with the Flexitouch® Plus system (FT)
Usual Care	Active comparator	Other: Usual CareComplete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age ≥ 18 years
Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
A diagnosis of either internal or external head and neck lymphedema
At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening

Key exclusion criteria (6 listed)

Previous APCD or Usual Care treatment for HNC LEF
Acute facial infection (e.g., facial or parotid gland abscess)
Known carotid sinus hypersensitivity syndrome
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)
Internal jugular venous thrombosis (within 3 months)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Advanced Pneumatic Compression Device (APCD)Also: Flexitouch, Flexitouch PlusOnce daily treatment with Flexitouch Plus.	Device	Advanced Pneumatic Compression Device (APCD)
Usual CareAlso: Complete Decongestive Therapy (CDT), Manual Lymphatic Drainage (MLD)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	Usual Care

Primary outcome

Internal Lymphedema - Endoscopy
Time frame: Change from Baseline at 2 months, 4 months, 6 months
The change in average site score from baseline assessed via endoscopy using the Modified Patterson Scale. The range for each site was 0-3: Normal, Mild, Moderate, Severe. A lower score means a better outcome.
Internal Lymphedema - CT Imaging
Time frame: Change from Baseline at 2 months, 6 months
The changes in fat stranding 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.
Internal Lymphedema - CT Imaging
Time frame: Change from Baseline at 2 months, 6 months
The changes in epiglottic thickness, and prevertebral soft tissue (PVST) using the CT Lymphedema and Fibrosis Assessment Tool (CT-LEFAT). Epiglottis and PVST are measured in mm. A lower measurement means a better outcome.
External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading
Time frame: Change from Baseline at 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 Grading criteria (HN-LEFG). 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.
External Lymphedema - Digital Photography
Time frame: Change from Baseline at 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%.
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey
Time frame: Change from Baseline at 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 (1-Slight to 5-Severe), then added together. The values represent the mean score change from baseline. Score range: 0-10 (0 = symptom not present). A lower score means a better outcome.
Physical Function - Vanderbilt Head and Neck Symptom Survey
Time frame: Change from Baseline at 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.
Quality of Life - Linear Analog Self-Assessment
Time frame: Change from Baseline at 2 months, 4 months, 6 months
Quality of life is assessed using the Linear Analog Self-Assessment. The overall well-being score ranges from 0-10 (0-As bad as it can be to 10-As good as it can be). The value represents the change from baseline. A positive change indicates an improvement.
Work and Activity - Work Productivity and Activity Impairment Questionnaire
Time frame: Change from Baseline at 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. The values represent the difference from baseline percentage. A greater negative number indicates a greater reduction in impairment. Total score range: 0-100%
Perceived Self-management Capacity - Perceived Medical Condition Self-Management Scale
Time frame: Change from Baseline at 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.
Body Image - Body Image Quality of Life Inventory
Time frame: Change from Baseline at 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. The values represent the change from baseline. A higher score indicates a better outcome.
Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool
Time frame: Change from Baseline at 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 will be evaluated.
Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool
Time frame: Change from Baseline at 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 fat, carbohydrate, fiber, sugars, and protein will be evaluated.

Results and safety

Results posted to the registry on 2 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Advanced Pneumatic Compression Device (APCD)	119	101
Usual Care	117	87

Primary outcome: Internal Lymphedema - Endoscopy

Time frame: Change from Baseline at 2 months, 4 months, 6 months. Median (Inter-Quartile Range). Unit: Score on a scale

Measure	Advanced Pneumatic Compression Device (APCD) n = 59	Usual Care n = 56
2-month Visit	-0.12 (-0.38 to 0.00)	-0.06 (-0.33 to 0.11)
4-month Visit	-0.21 (-0.44 to 0.00)	-0.16 (-0.40 to 0.00)
6-month Visit	-0.26 (-0.53 to 0.00)	-0.23 (-0.47 to -0.01)

Population analysed: The number of participants analyzed may differ from the overall number of patients analyzed due to the assessments not completed or incomplete, participant withdrawal, or death.

Primary outcome: Internal Lymphedema - CT Imaging

Time frame: Change from Baseline at 2 months, 6 months. Median (Inter-Quartile Range). Unit: Score on a scale

Measure	Advanced Pneumatic Compression Device (APCD) n = 90	Usual Care n = 62
Fat Stranding Total Score Change: 2-month Visit	0.00 (-0.17 to 0.20)	0.00 (-0.08 to 0.25)
Fat Stranding Total Score Change: 6-month Visit	0.00 (-0.38 to 0.17)	0.00 (-0.25 to 0.25)

Population analysed: The number of participants analyzed may differ from the overall number of patients analyzed due to the assessments not completed or incomplete, participant withdrawal, or death.

Primary outcome: Internal Lymphedema - CT Imaging

Time frame: Change from Baseline at 2 months, 6 months. Median (Inter-Quartile Range). Unit: mm

Measure	Advanced Pneumatic Compression Device (APCD) n = 95	Usual Care n = 72
Epiglottis Thickness Change: 2-month Visit	-0.10 (-0.70 to 0.75)	-0.20 (-0.80 to 0.50)
Epiglottis Thickness Change: 6-month Visit	-0.60 (-1.35 to 0.20)	-0.55 (-1.00 to 0.08)
PSVT Change: 2-month Visit	-0.40 (-1.40 to 0.80)	-0.20 (-0.85 to 0.65)
PSVT Change: 6-month Visit	-0.60 (-1.83 to 0.12)	-1.10 (-2.00 to -0.12)

Population analysed: The number of participants analyzed may differ from the overall number of patients analyzed due to the assessments not completed or incomplete, participant withdrawal, or death.

Primary outcome: External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading

Time frame: Change from Baseline at 2 months, 4 months, 6 months. Median (Inter-Quartile Range). Unit: Score on a scale

Measure	Advanced Pneumatic Compression Device (APCD) n = 105	Usual Care n = 89
Total Score Change: 2-month Visit	-1.00 (-2.00 to 0.00)	0.00 (-3.00 to 1.00)
Total Score Change: 4-month Visit	-1.00 (-3.00 to 0.00)	0.00 (-4.00 to 1.00)
Total Score Change: 6-month Visit	-2.00 (-4.00 to 0.00)	-1.00 (-3.00 to 1.00)

Population analysed: The number of participants analyzed may differ from the overall number of patients analyzed due to the assessments not completed or incomplete, participant withdrawal, or death.

Adverse events

Time frame: From randomization through study completion (6-month Visit Assessments).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advanced Pneumatic Compression Device (APCD)	0 of 119 (0%)	0 of 119 (0%)	1 of 119
Usual Care	0 of 117 (0%)	0 of 117 (0%)	2 of 117

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41574713Murphy BA, Smith DK, Kline-Quiroz CM, Jensen KM, Sukari AW, Bhayani MK, Mehta V, Quon H, Shah JL, Willey CD, Dunlap NE, Lee HK, Aulino JM, Ridner SH. Short-Term Outcomes of Advanced Pneumatic Compression Device Versus Usual Care Therapy for Head and Neck Cancer-Related Lymphedema: A Multi-Site Randomized Clinical Trial. Head Neck. 2026 Apr;48(4):1077-1087. doi: 10.1002/hed.70155. Epub 2026 Jan 23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barbara Murphy, MD principal investigator

Vanderbilt University Medical Center

Sheila Ridner, RN, PhD principal investigator

Vanderbilt University

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Advanced Pneumatic Compression Device (APCD) in people with Lymphedema and Lymphedema of Face, run by Tactile Medical at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Internal Lymphedema - Endoscopy (time frame: Change from Baseline at 2 months, 4 months, 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04797390, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.