CLINICAL TRIAL

CDT with Negative Pressure for Lymphedema

Recruiting · 18+ · Female · Nashville, TN

This study is evaluating whether a combination of treatments may be more effective for individuals with secondary lymphedema.

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About the trial for Lymphedema

Eligible Conditions
Lymphedema · Lymphedema, Secondary

Treatment Groups

This trial involves 2 different treatments. CDT With Negative Pressure is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CDT with Negative Pressure
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
CDT alone
PROCEDURE

Eligibility

This trial is for female patients aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Females with a diagnosis of secondary arm and/or upper quadrant lymphedema following cancer treatments
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At baseline and at 6-8 weeks following the completion of each therapy
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At baseline and at 6-8 weeks following the completion of each therapy.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CDT with Negative Pressure will improve 1 primary outcome and 2 secondary outcomes in patients with Lymphedema. Measurement will happen over the course of At baseline and at 6-8 weeks following the completion of each therapy.

Assessing a Change in Lymphatic Stasis
AT BASELINE AND AT 6-8 WEEKS FOLLOWING THE COMPLETION OF EACH THERAPY
Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography at baseline and following course of each treatment (cross over design)
Assessing a Change in Bioimpedance Spectroscopy (BIS)
AT BASELINE AND AT 6-8 WEEKS FOLLOWING THE COMPLETION OF EACH THERAPY
BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design)
Assessing a Change in Limb Volume
AT BASELINE AND AT 6-8 WEEKS FOLLOWING THE COMPLETION OF EACH THERAPY
Volume quantified using Perometer at baseline and following course of each treatment (cross over design)

Who is running the study

Principal Investigator
M. D.
Prof. Manus Donahue, Associate Professor
Vanderbilt University Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of lymphedema?

It is important to note that many things can resemble the symptoms of lymphedema. Signs of lymphedema include impaired skin circulation that appears as cyanosis or coolness to the skin and a dull, nonreactive capillary refill.

Anonymous Patient Answer

Can lymphedema be cured?

Lymphedema can be treated at all stages, with a low recurrence or amputation risk even after an extended interval, provided that patient selection is done correctly and treatment protocols are maintained. More accurate diagnostic and assessment methods are needed in order to increase the cure rate of lymphedema.

Anonymous Patient Answer

How many people get lymphedema a year in the United States?

Approximately 20 million Americans have lymphedema at some point in time and more than 5 million Americans get total or progressive lymphedema. Lymphedema may have an impact on many aspects of life. The incidence of lymphedema is difficult to predict but is unlikely to be much lower than the incidence rates quoted in this report.

Anonymous Patient Answer

What are common treatments for lymphedema?

Treatment for lymphedema varies widely but is highly effective in minimizing edema, pain, and functionality loss. These procedures may include manual therapy, skin grafts, or a combination of procedures. Further studies are needed to identify the ideal treatment regimen for lymphedema. summary: This article describes common treatments for a condition of the body including lymphedema and lymphatic vessel disease.

Anonymous Patient Answer

What causes lymphedema?

Chronic lymphedema is related to the progressive failure of lymphatic channels. Lymph nodes play an important role in the initial development of lymphedema. Tissue damage to lymphatics appears to be related to lymph node failure.

Anonymous Patient Answer

What is lymphedema?

This clinical condition may be treated by physiotherapy, and sometimes surgery may be necessary. Treatment options include patient education, massage therapy and compression garments. In cases of secondary lymphedema, which are commonly related to breast cancer, compression stockings do not have proven advantages in the treatment. Results from a recent paper showed that in case of secondary lymphedema, conservative treatment with an osmosis dressing has a high efficacy for management of swelling, with minimal complications. In primary lymphedema, our results pointed the importance of correcting and preventing secondary causes (e.g. the use of a compression splint).

Anonymous Patient Answer

What is the latest research for lymphedema?

Although we now have several effective treatments for lymphoedema, these need to be further researched to make sure that they are being prescribed to those in need.\n

Anonymous Patient Answer

What is the average age someone gets lymphedema?

The average age when lymphedema is first noticed is 26 years. It is more common after menopause and childbirth or other surgeries. This is the one most frequently seen in a US cohort (about 41 %). It is slightly more common in females, and usually has no known causes.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphedema?

More research is required to determine what treatments are potentially helpful in managing lymphedema. In addition, lymphedema is a serious and chronic, incurable disease for some people. As such its management can be difficult not only for the patient but even for his/her family members. Effective and efficient treatment of lymphedema will be a tremendous boon to both the patient as well as his/her family members.

Anonymous Patient Answer

How serious can lymphedema be?

Lymphedema has a serious potential to become chronic. With this potential for acquiring chronic problems related to edema, the importance of prevention with regards to this condition must be reconsidered.

Anonymous Patient Answer

Is cdt with negative pressure safe for people?

In our opinion it is possible to carry out treatment of lymphedema with negative pressure. Its success depends primarily on the person, the characteristics and location of the disease, the stage of the disease and the patient's motivation to the treatment. There are also a number of cases when it is difficult to carry out treatment. In our opinion it is necessary to keep open the possibility of the application of the method. In the future this method will be helpful in the therapy after breast cancer treatment.

Anonymous Patient Answer

Does cdt with negative pressure improve quality of life for those with lymphedema?

CDT can be effective for treatment of chronic lymphedema. We were unable, however, to find evidence to support our earlier finding that NBAD and compression garments result in higher quality of life.

Anonymous Patient Answer
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