Advanced Pneumatic Compression Device for Lymphedema

Recruiting at 9 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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares the effectiveness of an air pressure device (APCD) to standard treatment in reducing swelling and improving quality of life for head and neck cancer survivors. The device works by gently massaging the swollen areas to help move excess fluid out of the tissues.

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 data supports the effectiveness of the Advanced Pneumatic Compression Device treatment for lymphedema?

Research shows that advanced pneumatic compression devices (APCDs) can effectively reduce arm swelling and tissue water in patients with lymphedema after breast cancer treatment. Additionally, APCDs have been found to improve the quality of life for patients with lower-extremity lymphedema by mimicking a functional drainage system. ^{1 2 3 4 5}

Is the Advanced Pneumatic Compression Device safe for humans?

Research shows that advanced pneumatic compression devices are generally safe for treating lymphedema, a condition involving swelling due to fluid buildup, in both the arms and legs. ^{1 2 3 6 7}

How is the Advanced Pneumatic Compression Device treatment different from other treatments for lymphedema?

The Advanced Pneumatic Compression Device (APCD) is unique because it mimics a functional drainage system by targeting lymphatic beds, offering a novel way to manage lymphedema. It provides focused treatment with different cycles and is used as part of a self-care regimen, although it requires the patient to be immobile during use. ^{1 2 3 4 8}

Research Team

Barbara Murphy, MD

Principal Investigator

Vanderbilt University Medical Center

Sheila Ridner, RN, PhD

Principal Investigator

Vanderbilt University

Eligibility Criteria

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

Age ≥ 18 years

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. [2021]

2. United States 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). [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Pneumatic Compression Improves Quality of Life in Patients with Lower-Extremity Lymphedema. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Lymphoedema management with the LymphFlow Advance pneumatic compression pump. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Development of a framework for pneumatic device selection for lymphedema treatment. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Usability evaluation of a novel compact pneumatic compression device for the treatment of lymphoedema: Pilot study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Soft Robotic Sleeve for Compression Therapy of the Lower Limb. [2021]