LymphaVibe for Upper Extremity Lymphedema

Overseen By Andre Muelenaer, MD

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

Trial Summary

What is the purpose of this trial?

Lymphedema is a painful and disfiguring condition related to the buildup of protein-rich fluid in the body's tissues. 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. This device has been previously studied on healthy people that do not have a diagnosis of lymphedema. It was found that using the device on them does not cause significant changes to their vital signs or level of pain. Side effects are reported sometimes; however, these are to be expected and are also frequently reported when people receive the standard of care for their lymphedema. Patients who have diagnosed lymphedema will be approached to participate in this study as part of their care. Participants will wear this device for approximately 40 minutes and then have certain measurements taken before and after doing so. These measurements include the size of their arm, how much pain/discomfort they are currently in, and if they experienced any side effects. After getting treatment with the device, they will receive the standard of care treatment for their lymphedema from their provider. After the standard of care has concluded, the previously mentioned measurements will be repeated. This data will be put together and analyzed to look for differences in arm size before and after treatment with the device as well as to look for the prevalence of side effects.

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 data supports the effectiveness of the treatment LymphaVibe for upper extremity lymphedema?

Research on similar treatments, like compression therapy combined with exercises or devices, shows positive results in reducing arm lymphedema. Additionally, studies on other treatments, such as the use of oak wood extract for leg lymphedema, have shown significant reductions in swelling, suggesting that similar approaches might be effective for upper extremity lymphedema. ^{1 2 3 4 5}

Research Team

Ralph Brown, MD

Principal Investigator

Carilion Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Germany 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. [2022]

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

French Oak Wood (Quercus robur) Extract (Robuvit) in Primary Lymphedema: A Supplement, Pilot, Registry Evaluation. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. [2021]

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

Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. [2018]

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

Follow-up study of upper limb lymphedema patients treated by microsurgical lymphaticovenous implantation (MLVI) combined with compression therapy. [2007]