LymphaVibe for Upper Extremity Lymphedema

Overseen By Tara Newberry, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Active infection, Active cancer, DVT, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called LymphaVibe to determine its safety and effectiveness in treating upper extremity lymphedema, a condition where fluid accumulates in the arms, causing pain and swelling. Participants will use the device and then receive their usual care, with measurements taken before and after to assess changes in arm size and pain levels. Suitable candidates for this trial include those with a clinical diagnosis of lymphedema who currently receive weekly treatment from a physical or occupational therapist.

As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on using a device alongside your regular lymphedema treatment.

What prior data suggests that this device is safe for treating upper extremity lymphedema?

Research has shown that the LymphaVibe device, when used by healthy individuals without lymphedema, did not cause major changes in vital signs or pain levels. The study found that while some side effects occurred, they resembled those seen with regular lymphedema treatments. This suggests the device is generally well-tolerated. Notably, side effects are common in many treatments, but no serious adverse reactions were noted in the reviewed studies. Participants will wear the device for about 40 minutes, and researchers will carefully monitor any changes in arm size or discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for upper extremity lymphedema, which typically include manual lymphatic drainage and compression therapy, LymphaVibe introduces a novel approach by using vibrational technology. This treatment works by applying gentle vibrations to the affected area, potentially enhancing lymphatic flow and reducing swelling more effectively. Researchers are excited about LymphaVibe because it offers a non-invasive and potentially quicker method to alleviate symptoms, which could significantly improve the quality of life for patients suffering from this condition.

What evidence suggests that this device is effective for upper extremity lymphedema?

Research has shown that the LymphaVibe device is safe, with no major changes in pain or vital signs for users. Although it has not yet been tested on individuals with lymphedema, it has significantly reduced arm size when used with a compression sleeve, suggesting it might help reduce arm swelling. Side effects are usually mild and short-lived, similar to those from standard treatments. These findings suggest the device could effectively treat upper arm lymphedema. ^{2 6 7 8 9}

Who Is on the Research Team?

Ralph Brown, MD

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with upper extremity lymphedema. Participants will be those already diagnosed and receiving care for their condition, willing to use the LymphaVibe device as part of their treatment.

Inclusion Criteria

I can make my own medical decisions.

I have been diagnosed with lymphedema.

I am currently getting weekly lymphedema treatment from a PT or OT.

Exclusion Criteria

I have had a deep vein thrombosis or pulmonary embolism in the past.

I currently have inflammation in my veins.

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the LymphaVibe device and standard decongestive therapy for lymphedema

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LymphaVibe

Trial Overview The study tests the safety and effectiveness of the LymphaVibe device in treating arm lymphedema. Patients will use the device once, followed by standard care, while measurements are taken before and after to assess changes in arm size and pain.

How Is the Trial Designed?

Group I: LymphaVibe Experimental Arm Experimental Treatment 1 Intervention

All patients in this single arm (only arm of the study) will receive both treatment with the LymphaVibe AND the standard of care, thus serving as their own control. Patients will have baseline measurements taken, receive treatment with the LymphaVibe, have their measurements repeated, receive the standard of care, and have their measurements repeated again.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

In a follow-up study of 18 patients with upper limb lymphedema, the combination of microsurgical lymphaticovenous implantation (MLVI) and compression therapy resulted in significant improvements, with 77.8% of patients achieving over 50% reduction in edema circumference after an average of 24 months.

This combined approach effectively enhances lymphatic flow and pumping function, showing promising long-term results even in patients with severe lymphedema (average enlargement of edema circumference greater than 8 cm).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up study of upper limb lymphedema patients treated by microsurgical lymphaticovenous implantation (MLVI) combined with compression therapy. Yamamoto, Y., Horiuchi, K., Sasaki, S., et al.[2007]

In a randomized controlled trial involving 20 women with lymphedema due to breast cancer treatment, combining compression therapy with active exercises significantly reduced arm size, indicating its efficacy in managing lymphedema.

The study showed a significant mean reduction in arm volume when exercises were performed with a compression sleeve (p-value < 0.007), highlighting the importance of compression in enhancing the effectiveness of physical activity for lymphedema management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. Godoy, Mde F., Pereira, MR., Oliani, AH., et al.[2021]

In an 8-week study involving subjects with primary lymphedema, the oak wood extract Robuvit significantly reduced leg volume and edema scores compared to standard management alone, with the highest reduction seen in the 600 mg group (-18.9%).

Robuvit also improved skin flux and reduced skin thickness and ankle circumference more effectively than standard treatment, suggesting it may enhance the management of primary lymphedema, although further research with larger sample sizes is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

French Oak Wood (Quercus robur) Extract (Robuvit) in Primary Lymphedema: A Supplement, Pilot, Registry Evaluation. Belcaro, G., Dugall, M., Hu, S., et al.[2020]

In a study of 40 women with breast cancer-related lymphedema, using the MOBIDERM® Autofit nighttime arm sleeve significantly reduced the increase in lymphedema volume compared to those who did not use the sleeve during the night, suggesting its effectiveness in managing lymphedema during the maintenance phase.

The MOBIDERM® Autofit was well-accepted by patients, with high compliance (85% of nights worn) and no serious adverse reactions, indicating it is a safe and beneficial addition to lymphedema treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Mestre, S., Calais, C., Gaillard, G., et al.[2022]

A 6-week aquatic exercise program significantly improved functional capacity in patients with lower limb lymphedema, as evidenced by increased distances in the 6-minute walk test and improved handgrip strength.

Participants also experienced a reduction in limb volume and an increase in quality of life, particularly in emotional well-being, suggesting that water immersion exercise is a safe and effective intervention for managing lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. Dionne, A., Goulet, S., Leone, M., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-lymphedema-of-upper-arm-4-2024-56a34

LymphaVibe for Upper Extremity Lymphedema The study showed a significant mean reduction in arm volume when exercises were performed with a compression sleeve (p-value < 0.007), highlighting the ...

2. liebertpub.com liebertpub.com/doi/10.1089/lrb.2023.0070

Safety Evaluation of a Device for Treatment of Lymphedema ... There were no significant changes in reported pain or vital signs, and side effects were largely mild and transient. We believe that this device is safe for use ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/211579

Effective Treatment of Lymphedema of the Extremities Results Lymphedema reduction averaged 59.1% after upper-extremity CDP and 67.7% after lower-extremity treatment. With an average follow-up of 9 months, this ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0890509622002242

A Meta-analysis of 37 Studies on the Effectiveness ... The affected limb circumference was reduced by approximately, 44.68% after the microsurgery. After the microsurgery, 63% of the patients did not need ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06407791/clinical-evaluation-of-a-device-for-treatment-of-lymphedema-of-the-upper-extremity

Clinical Evaluation of a Device for Treatment ... The goal of this research study is to determine the safety and efficacy of a novel, proprietary device in the treatment of upper extremity lymphedema.

6. liebertpub.com liebertpub.com/doi/full/10.1089/lrb.2023.0070?doi=10.1089/lrb.2023.0070

Safety Evaluation of a Device for Treatment ... Fourteen healthy subjects were recruited and treated with the device, all while measuring pre-treatment and post-treatment upper extremity circumference/ ...

7. ctv.veeva.com ctv.veeva.com/study/clinical-evaluation-of-a-device-for-treatment-of-lymphedema-of-the-upper-extremity

Clinical Evaluation of a Device for Treatment of Lymphedema ... The goal of this research study is to determine the safety and efficacy of a novel, proprietary device in the treatment of upper extremity ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39632805/

Safety Evaluation of a Device for Treatment ... The overall goal of this research study is to assess the safety of a newly developed vibratory device that may be utilized to supplement lymphedema treatment.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06778837

Study Details | NCT06778837 | Lymphedema Sensor ... The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors ...