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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using a gentle suction device along with standard therapy is more effective for reducing swelling in patients with arm or upper body lymphedema after cancer treatments. The suction helps soften hardened tissue, making it easier for massage and compression techniques to reduce swelling. A similar method has been shown to be a safe and reliable way to reduce excess fat in chronic arm lymphedema following breast cancer treatment.

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 combined decongestive therapy (CDT) safe for humans?

Complex decongestive therapy (CDT) is considered non-invasive, painless, and without side effects, making it generally safe for humans. ^{1 2 3 4 5}

How does the treatment of CDT with Negative Pressure differ from other treatments for lymphedema?

The treatment of CDT with Negative Pressure is unique because it combines complete decongestive therapy (CDT), which is a standard non-invasive treatment involving manual lymph drainage, compression, exercise, and skincare, with negative pressure therapy, which may enhance fluid removal and improve outcomes. This combination could offer a novel approach by potentially increasing the effectiveness of fluid reduction compared to CDT alone. ^{2 4 6 7 8}

Research Team

Manus M Donahue, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: CDT with Negative Pressure Experimental Treatment 1 Intervention

CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)

Group II: CDT alone Active Control 1 Intervention

CDT alone without LymphaTouch 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+

Findings from Research

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]

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]

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]

References

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

Combined decongestive therapy and reduction of pain and heaviness in patients with breast cancer-related lymphedema. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Application of complete decongestive therapy after lymphaticovenular anastomosis of the lower limb combined with liposuction-A retrospective study research. [2023]

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

Regular Compression Therapy May Not Be Necessary for Lymphedema in Arms without a Subcutaneous Echo-Free Space. [2020]

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

Effectiveness of six-step complex decongestive therapy for treating upper limb lymphedema after breast cancer surgery. [2022]

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

Predictive factors of response to phase I complete decongestive therapy in upper extremity lymphedema following breast carcinoma in Iran. [2014]

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

Prospective trial of complete decongestive therapy for upper extremity lymphedema after breast cancer therapy. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of manual lymphatic drainage in intensive phase I therapy of breast cancer-related lymphedema-a retrospective analysis. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of complex decongestive physiotherapy for malignant lymphedema: a pilot study. [2021]