Treatment for Lymphedema

1
Effectiveness
1
Safety
Rush University Medical Center, Chicago, IL
Lymphedema+4 More
Eligibility
18+
All Sexes
Eligible conditions
Lymphedema

Study Summary

This study is evaluating whether a compression device may help reduce swelling in the arms of individuals who have had cancer.

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Eligible Conditions

  • Lymphedema
  • Lymphedema, Secondary
  • Lymphedema of Face
  • Lymphedema Due to Radiation
  • Lymphedema; Surgical

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 11 primary outcomes in patients with Lymphedema. Measurement will happen over the course of Changes between Baseline, 2 months, 6 months.

Month 6
Body image - Body Image Quality of Life Inventory (BIQLI)
Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS)
Quality of Life - Linear Analog Self-Assessment
Reduction in Swelling/Inflammation - Digital Photography
Reduction in Swelling/Inflammation - Endoscopy
Reduction in Swelling/Inflammation - Grading of External Lymphedema
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey
Symptom Burden and Functional Impairment - Vanderbilt Head and Neck Symptom Survey
Work and Activity - Work Productivity and Activity Impairment Questionnaire
Month 6
Reduction in Swelling/Imaging - CT

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Advanced Pneumatic Compression Device (APCD)

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment 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.

Advanced Pneumatic Compression Device (APCD)
Device
Daily self-administered treatment with the Flexitouch® Plus system (FT)
Usual Care
Other
Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: changes between baseline, 2 months, 4 months, 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly changes between baseline, 2 months, 4 months, 6 months for reporting.

Closest Location

Rush University Medical Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lymphedema or one of the other 4 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must be able to speak and understand English
Age ≥ 18 years
Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
A diagnosis of either internal or external head and neck lymphedema
At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation

Patient Q&A Section

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

Does lymphedema run in families?

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Familial occurrence seems to be highly variable, depending on the nature of the mutations (homozygous or heterozygous). In the absence of a mutation (e.g. nonsense or missense mutations), familial occurrence is likely to be of genetic origin.

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What are common treatments for lymphedema?

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There is no single standard of care for lymphedema treatment. Patient and provider preference should guide care for any given patient. There have become many options for treatment of lymphedema. Most of these options have the potential to cause significant complications. Most lymphedema doctors are aware of many of these options and will discuss them with their patients. When considering lymphedema treatment, the goal should be symptom relief, with the aim to improve the quality of life of patients. However, because there is considerable variability in the efficacy and adverse-effects profile of individual agents; they should be tailored to the patient.

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Can lymphedema be cured?

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There are more and more data that show that treating lymphedema can prevent it. There are two types of treatments for lymphedema: physiologic and surgical, all of them are equally effective. Only the duration is not the same. Some patients with lymphedema can live as if they were cured and they can even keep on riding a bicycle without pain. If it is a physiologic Lymphedema, maybe after a few years when the lymph can be reabsorbed, it will vanish. However, the lymph cannot be really erased. The only way to erase this chronic disease is by using surgeries. If it is a secondary lymphedema the results depend on the cause of acquiring the disease.

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

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around 7,500 people develop lymphedema a year in the United States and around 2,500 people become completely edentulous. The disease affects an average of 1.3 per 100,000 people annually. Most cases are confined to the upper extremities, with only 25.8% happening in the lower extremities. Lymphedema can be managed successfully with conservative treatment. Surgery, even if necessary, is a rarely used treatment option.

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What are the signs of lymphedema?

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This article highlights the signs of lymphedema and provides prevention and treatment information. If one has lymphedema, one needs to know the signs of it in order to be aware of her/his condition.

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What causes lymphedema?

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Lymphedema is a complex disease caused by a number of factors. Its development is affected by an individual's anatomy of the lymph system. Women are at increased risk of developing lymphedema and have a number of risk factors including surgeries in the groin or groin and axilla, radiation therapy to the lower chest, weight loss and pregnancy or childbirth. Risk factors for lymphedema during pregnancy include previous surgery on the pelvic region, pregnancy at an advanced stage, and a history of breast or ovarian cancer.

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What is lymphedema?

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Lymphedema is the swelling of the arm or leg caused by an inability to pump or push the lymph away. This swelling may occur in women as a result of the removal of the lymph nodes during surgery, during childbirth, or as a result of cancer or other disease. In addition to swelling it may worsen discomfort and worsen walking and the ability to dress. Although a wide variety of treatments are available, no specific treatment is available for lymphedema.

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Who should consider clinical trials for lymphedema?

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Clinical trials are worthwhile in some situations and potentially important in the treatment of lymphedema. Clinical trials should be specifically designed to take into account all key considerations, including what the research question may be, what treatments are available, and what they are in common. They need to last at least one year in order to be useful. Clinical trials can help to determine whether a new treatment is better, similar, or worse than an established treatment for a specific condition. It is imperative that clinical trials receive rigorous oversight to ensure that the research has the quality to be useful. Such oversight should be required by both the academic institution conducting the studies and the regulators.

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What are the common side effects of treatment?

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Side effects were usually mild even though in some cases there were slight symptoms and there were people reporting significant side effects. Taking the medication at a prescribed frequency was well tolerated. No significant side effects were reported for rheumatoid arthritis, ankylosing spondylitis and chronic obstructive pulmonary disease.

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What are the latest developments in treatment for therapeutic use?

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New treatment technologies can be classified on the basis of their mechanism of action. Some drugs are also classified on the basis of their mechanism of action in use in clinical practice.

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What does treatment usually treat?

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Lymphedema is a chronic disease that often requires a prolonged course of treatment. However, this is sometimes under-recognised by many patients and care teams. Improved education and increased referral pathways are required. I argue that in addition to the chronic nature of lymphedema, the treatment algorithm is also underpinned by the 'disease model' that drives the treatment and management. This model is a framework that has been used to analyse disease patterns and inform treatment strategies. Treating lymphedema with adequate and repeated treatment, focusing on compression garments, is necessary to reduce and manage disease progression. Treating patients with lymphoedema for prolonged periods, in an ongoing way (e.g.

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Has treatment proven to be more effective than a placebo?

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In patients who were given a placebo, a gradual improvement occurred at three months after injection with a solution of lidocaine and epinephrine (L&E) and at six months post injection, although a more rapid response was registered in patients who had received a treatment. The use of a low concentration of lidocaine and epinephrine, when given sublingually to patients with chronic lymphedema, demonstrated sustained benefit in most patients, the longest responders being those who had received a treatment.

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