Advanced Pneumatic Compression Device for Lymphedema

Recruiting at 10 trial locations

Overseen By Robyn Schacherer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tactile Medical

Disqualifiers: Acute facial infection, Carotid disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

236 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well an Advanced Pneumatic Compression Device (APCD) manages lymphedema and fibrosis compared to usual care in head and neck cancer survivors. Participants will either use the APCD at home or follow traditional therapy with a lymphedema specialist. It suits individuals who have completed cancer treatment, have a lymphedema diagnosis in the head or neck, and experience significant swelling symptoms. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future lymphedema care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this advanced pneumatic compression device is safe for lymphedema management?

Research has shown that the Advanced Pneumatic Compression Device (APCD) is generally safe for treating lymphedema in patients with head and neck cancer. A previous study specifically confirmed its safety and practicality for these patients. Another study with 71 patients who had lymphedema in their lower body found that symptoms improved without major side effects from using the APCD. Although less safety data exists for the head and neck area, the device's overall history suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Advanced Pneumatic Compression Device (APCD) for lymphedema because it offers a new way to manage this condition right at home. Unlike the traditional Complete Decongestive Therapy (CDT), which requires visits to a lymphedema therapist, the APCD allows for daily self-administered treatment using the Flexitouch® Plus system. This method could make treatment more convenient and accessible, potentially improving adherence and outcomes. Additionally, the device's advanced pneumatic technology might enhance fluid movement and reduce swelling more effectively than current options.

What evidence suggests that this device is effective for lymphedema?

Research has shown that Advanced Pneumatic Compression Devices (APCDs), which participants in this trial may receive, effectively manage lymphedema, particularly in head and neck cancer survivors. A large study found that using an APCD reduced lymphedema symptoms over six months. Another study confirmed that these devices are safe and practical for treating lymphedema caused by other conditions in this patient group. Additionally, APCDs have proven effective for treating leg lymphedema when used at home. These devices help improve quality of life by easing lymphedema symptoms. Meanwhile, the trial will also evaluate Usual Care, which includes Complete Decongestive Therapy (CDT) directed by a lymphedema therapist, as another treatment option. ^{1 2 3 4 6}

Who Is on the Research Team?

Barbara Murphy, MD

Principal Investigator

Vanderbilt University Medical Center

Sheila Ridner, RN, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who've finished cancer treatment with no active cancer, have head and neck lymphedema diagnosed, and experience related symptoms. It's not for those previously treated for this condition, with acute facial infections, carotid sinus hypersensitivity, recent severe carotid artery disease events or internal jugular venous thrombosis.

Inclusion Criteria

Must be able to speak and understand English

Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation

Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment

Exclusion Criteria

Previous APCD or Usual Care treatment for HNC LEF

Acute facial infection (e.g., facial or parotid gland abscess)

Known carotid sinus hypersensitivity syndrome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive self-administered APCD therapy or Usual Care for head and neck lymphedema

6 months

Baseline, 2 months, 4 months, 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Pneumatic Compression Device
• Usual Care

Trial Overview The study compares an Advanced Pneumatic Compression Device (APCD) to Usual Care in managing lymphedema and fibrosis in survivors of head and neck cancer. Participants will be randomly assigned to either the APCD group or receive standard care treatments.

How Is the Trial Designed?

Group I: Advanced Pneumatic Compression Device (APCD) Active Control 1 Intervention

Daily self-administered treatment with the Flexitouch® Plus system (FT)

Group II: Usual Care Active Control 1 Intervention

Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist

Who Is Running the Clinical Trial?

Tactile Medical

Lead Sponsor

Trials

16

Recruited

1,200+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

In a study involving 36 patients with arm lymphedema after breast cancer treatment, the advanced pneumatic compression device (APCD) led to a significant 29% reduction in arm edema, while the standard device (SPCD) resulted in a 16% increase in edema over 12 weeks.

The APCD also showed a 5.8% reduction in tissue water, indicating better efficacy in managing lymphedema compared to the SPCD, which had a 1.9% increase in tissue water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Fife, CE., Davey, S., Maus, EA., et al.[2021]

A 3-year study involving 18 patients with unilateral leg lymphedema demonstrated that high-pressure, long-duration pneumatic compression therapy significantly reduced limb circumference and improved tissue elasticity without any observed complications.

The therapy effectively compensates for the loss of lymphatic function by promoting fluid movement from swollen areas to regions with normal lymphatic drainage, making it a safe and effective treatment option for patients with lower limb lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. Zaleska, M., Olszewski, WL., Durlik, M.[2021]

In a study involving 50 women with breast cancer-related lymphedema, the novel nonpneumatic compression device (NPCD) significantly reduced limb edema volume by 64.6%, compared to a 27.7% reduction with the advanced pneumatic compression device (APCD).

The NPCD also led to higher patient adherence (95.6% vs 49.8%) and satisfaction (90% vs 14%) compared to the APCD, indicating it is a more user-friendly option for self-care in lymphedema treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE). Rockson, SG., Whitworth, PW., Cooper, A., et al.[2022]

Citations

1. investors.tactilemedical.com investors.tactilemedical.com/news-releases/news-release-details/landmark-study-demonstrates-sustained-clinical-benefits

News Release Details - Investors The six-month analysis, drawn from a large randomized controlled trial, showed improvement in lymphedema symptom burden for participants in both ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7767900/

a randomized wait-list controlled trial This trial supports the safety and feasibility of the APCD for the treatment of secondary lymphedema in head and neck cancer patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04797390

A Study Evaluating an Advanced Pneumatic Compression ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X24003615

Results from a comparative study to evaluate the treatment ... Objective. Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting.

5. tactilemedical.com tactilemedical.com/clinicians/clinical-evidence/

At-Home Treatment of Lymphedema Clinical Trials This randomized study compared commercially available basic pneumatic compression devices (PCD) to assess treatment satisfaction, perceived efficacy, and ...

6. mdpi.com mdpi.com/2813-3307/3/3/27

Non-Pneumatic Active Compression Device vs. Advanced ... Non-pneumatic compression devices (NPCDs) have been shown to be safe and more clinically effective in treating lymphedema (LED) than advanced pneumatic ...