Combined Therapies for Lymphedema Management

Overseen By Maria E Garza, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pacemakers, Bilateral lymphedema, Bioimplants, others

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

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a special technique called negative pressure therapy to the usual lymphedema treatment, known as Complete Decongestive Therapy (CDT), increases effectiveness. Lymphedema causes swelling, often after cancer treatments. Participants will try both the standard and combined treatments for a short period to assess which works better. Women experiencing arm or upper body swelling after cancer treatments might be suitable for this study.

As an unphased trial, this study provides participants with the opportunity to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Complete Decongestive Therapy (CDT) is a well-known and safe treatment for lymphedema. Many studies have found it effective in reducing swelling and increasing patient comfort, with no reported side effects.

Evidence regarding the addition of negative pressure therapy to CDT is still developing. One study examined the use of a device for negative pressure therapy and found no serious side effects. This suggests it might be safe to use with CDT, but further research is needed for confirmation.

Overall, both treatments in this trial appear to be well-tolerated based on current knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing lymphedema by combining Complete Decongestive Therapy (CDT) with LymphaTouch Negative Pressure. Unlike the standard CDT, which focuses on manual lymphatic drainage and compression, the addition of negative pressure aims to enhance lymph flow and reduce swelling more effectively. This method could offer a more efficient and potentially faster way to alleviate symptoms, providing a significant improvement over traditional therapies. By comparing CDT alone and CDT with negative pressure, the trial aims to reveal whether this combination can offer better outcomes for patients suffering from lymphedema.

What evidence suggests that this trial's treatments could be effective for lymphedema?

Research has shown that Complete Decongestive Therapy (CDT) effectively reduces lymphedema, a swelling often caused by cancer treatment. Studies indicate that CDT can decrease the size of the swollen limb, helping to manage the swelling. In this trial, participants will receive either CDT alone or CDT with Negative Pressure therapy. Adding Negative Pressure therapy to CDT might enhance these results. Early research suggests that using both methods together can improve lymphatic system function and relieve symptoms more effectively than CDT alone. This combination could offer a more effective option for those experiencing lymphedema after cancer treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Manus M Donahue, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for women who have arm or upper quadrant lymphedema after cancer treatment. They can't join if they have non-MRI compatible implants, metal fragments in their body, are pregnant (excluded only from MRI), have open wounds on ankles/feet, heart pacemakers, ferromagnetic bioimplants that could move, or had pre-existing lymphedema before cancer treatments.

Inclusion Criteria

I am a woman with swelling in my arm or upper body after cancer treatment.

Exclusion Criteria

Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI

You have metal fragments in or near your eyes, possibly from an injury or a job that involves working with metal.

I have swelling in both arms or upper body before cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CDT with LymphaTouch or CDT alone for 6 weeks, with a total of 9 therapy visits each lasting 75 minutes

6 weeks

9 visits (in-person)

Follow-up

Participants are monitored for changes in limb volume, bioimpedance spectroscopy, and lymphatic stasis after treatment

6-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CDT alone
• CDT with Negative Pressure

Trial Overview The study is testing whether using negative pressure therapy with complete decongestive therapy (CDT) works better than CDT alone for managing secondary lymphedema. It's a repeated-measures cross-over trial where participants will experience both interventions sequentially.

How Is the Trial Designed?

Group I: CDT Alone first, then CDT With Negative Pressure Experimental Treatment 2 Interventions

Participants randomized into a CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration). This is followed by a 6 month washout period, then a second intervention consisting of CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)

Group II: CDT With Negative Pressure first, then CDT Alone Active Control 2 Interventions

Participants randomized into a CDT with LymphaTouch Negative Pressure for 6 weeks, total of 9 therapy visits (75minutes duration). This is followed by a 6 month washout period, then a second intervention consisting of CDT alone without Negative Pressure for 6 weeks, total of 9 therapy visits (75minutes duration)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Complete decongestive therapy (CDT) effectively reduces limb girth and volume in patients with lymphedema, with significant improvements observed after 2-4 weeks of treatment, leading to decreased pain levels.

While quality of life improvements were noted, they were not statistically significant; however, patients reported a consistent increase in quality of life throughout the treatment and follow-up period, with many experiencing no pain by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective trial of complete decongestive therapy for upper extremity lymphedema after breast cancer therapy. Mondry, TE., Riffenburgh, RH., Johnstone, PA.[2019]

A six-step complex decongestive therapy (CDT) involving a foam granule bandage and air wave pressure therapy was found to be more effective than the conventional four-step CDT in reducing upper extremity lymphedema in 100 patients after breast cancer surgery.

Patients receiving the six-step CDT reported significantly reduced tightness and swelling in their limbs, indicating improved lymphatic circulation and overall quality of life after 20 treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of six-step complex decongestive therapy for treating upper limb lymphedema after breast cancer surgery. Zhang, HZ., Zhong, QL., Zhang, HT., et al.[2022]

A study involving 55 patients who underwent lymphaticovenular anastomosis (LVA) combined with liposuction showed that adherence to complete decongestive therapy (CDT) significantly improved lymphedema symptoms and quality of life over 12 months.

Patients who adhered to CDT (Group B) experienced greater reductions in lymphedema severity and better health outcomes compared to those who did not adhere (Group A), highlighting the importance of ongoing CDT after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of complete decongestive therapy after lymphaticovenular anastomosis of the lower limb combined with liposuction-A retrospective study research. Zhou, X., Ma, G., Qi, X., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22920313/

A systematic review of the evidence for complete ... CDT is seen to be effective in reducing lymphedema. This review focuses on original research about CDT as a bundled intervention and 2 individual components.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07217288

Complete Decongestive Therapy Versus Non-pneumatic ... The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT100521

Effectiveness of complete decongestive therapy (CDT) in ... Mean post treatment volume of affected limb at the end of 10th day was 329.93mL (249-400mL) showing an absolute reduction in mean volume of affected arm by ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148212002377

A Systematic Review of the Evidence for Complete ... This review focuses on original research about CDT as a bundled intervention and 2 individual components, manual lymph drainage and compression bandages.

5. link.springer.com link.springer.com/article/10.1007/s12032-024-02421-6

Effectiveness of complete decongestive therapy for upper ... This paper presents a systematic review (SR) of SRs on CDT's efficacy in BCRL, and the components of manual lymph drainage (MLD) and exercise.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7431294/

Effectiveness and Safety of Complete Decongestive Therapy ... The proper treatment of the CDT phase I ensures safety and a great reduction in edema in patients with lymphedema that predispose the success of phase II of ...

7. physio-pedia.com physio-pedia.com/Complete_Decongestive_Therapy_(CDT)

Complete Decongestive Therapy (CDT) Many studies have demonstrated the effectiveness of CDT for improving lymphedema symptoms such as swelling and pain. Historically, it is an intensive program ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208112000836

Complete Decongestive Therapy for Treatment of ... Complete decongestive therapy (CDT) is effective in reducing lymphedema, although the contribution of each individual complete decongestive therapy component ...

9. uptodate.com uptodate.com/contents/management-of-peripheral-lymphedema

Management of peripheral lymphedema - UpToDate Effectiveness of complete decongestive therapy — For patients with lymphedema, CDT is the mainstay of treatment. CDT (also called complex ...