CLINICAL TRIAL

Juzo Compression Sleeve and Glove for Breast Cancer Lymphedema

High Risk
Waitlist Available · 18+ · Female · Boston, MA

Early Intervention

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About the trial for Breast Cancer Lymphedema

Eligible Conditions
Breast Cancer Lymphedema · Lymphedema · Breast Neoplasms · Breast Cancer · Breast Cancer Treatment Related Lymphedema

Treatment Groups

This trial involves 2 different treatments. Juzo Compression Sleeve And Glove 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.
Juzo Compression Sleeve and Glove
DEVICE
Compression Sleeve Sensor
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eligible participants will demonstrate low volume swelling (RVC 5-<10%) >/=12 weeks postoperatively
You are female, >/= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (with or without contralateral prophylactic SLNB). show original
Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document. show original
Patients who have undergone ALND are at higher risk of BCRL than those who have undergone SLNB only. show original
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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: 1, 3, 6, 9 and 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 3, 6, 9 and 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1, 3, 6, 9 and 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Juzo Compression Sleeve and Glove will improve 1 primary outcome and 3 secondary outcomes in patients with Breast Cancer Lymphedema. Measurement will happen over the course of 4 Weeks.

Sensor Accuracy
4 WEEKS
Accuracy will be defined as sensor-detected wear within ±4.17% of true wear
4 WEEKS
Adherence rate to compression
4 WEEKS
Percentage of participants who wear the garment for >/=50% of the instructed time (>/=6 of 12 instructed hours per calendar day), >57% of calendar days (>/=4 days per week),
4 WEEKS
Arm Volume
1, 3, 6, 9 AND 12 MONTHS
Primary objective is efficacy of compression intervention to change rate of progression from low volume swelling (LVS) (relative volume change (RVC) 5-<10%) to breast cancer-related lymphedema (BCRL) (RVC >/=10%). Measurement of effect of the compression intervention will be completed with arm volume measurements using perometry (infrared optical electronic scanner) .
1, 3, 6, 9 AND 12 MONTHS
Questionnaire Completion
1, 3, 6, 9 AND 12 MONTHS
Percentage of participants who complete Breast Cancer and Lymphedema Symptom Experience Index and Functional Assessment of Cancer Therapy-- Breast Cancer questionnaires at each study visit per study protocol.
1, 3, 6, 9 AND 12 MONTHS

Who is running the study

Principal Investigator
A. T.
Alphonse Taghian,, MD PhD
Massachusetts General Hospital

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 common treatments for breast cancer lymphedema?

While physiotherapy is an effective treatment, it is also very expensive. Findings from a recent study showed an increase in breast cancer lymphedema therapy utilization, which was a consequence of an increased understanding of the risks and consequences of lymphedema. Appropriate and effective education on breast cancer lymphedema management is imperative to support and prevent the condition.

Anonymous Patient Answer

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

There are variations in the magnitude and incidence of lymphedema reported by different sources. Findings from a recent study identified a number of sources and their estimates of cases of breast cancer lymphedema. This information and methods have been validated in a community based sample and may be used for future research studies.

Anonymous Patient Answer

What is breast cancer lymphedema?

Lymphedema can affect physical and psychosocial functioning of breast cancer survivors, but the effect is not consistent. It is evident, however, that lymphedema remains an under-recognised problem. Strategies to identify and provide supportive nursing interventions are required to address this potentially distressing and disabling condition.

Anonymous Patient Answer

What causes breast cancer lymphedema?

Current research is uncovering more causes of breast cancer edema. However, some issues can still not be solved. For instance, the cause of the progressive pain experienced by breast cancer edema patients remains unclear. It is still uncertain which gene participates in the development of breast cancer edema. Some genes, such as the gene F871V, could be new causes for breast cancer edema.

Anonymous Patient Answer

Can breast cancer lymphedema be cured?

Based on previous retrospective and prospective studies, the treatment of breast cancer-associated lymphedema resulted in subjective, but not objective, complete resolution of lymphedema in over 80% of those treated. Although a randomized prospective study is needed to confirm these findings, we suggest a randomized trial to test one of two interventions: conservative and aggressive treatment, or observation in patients with lymphedema.

Anonymous Patient Answer

What are the signs of breast cancer lymphedema?

Signs and symptoms of breast cancer lymphoedema include the progressive swelling of the arm, leg, or buttocks. There may also be swelling at the back of the neck, around the nipple, or around the arm when the person is lying down. There may also be pain caused by lymphoedema. Patients must be aware of the symptoms of breast cancer lymphoedema to get best outcomes with the use of compression garments during treatment and after surgery.

Anonymous Patient Answer

What are the common side effects of juzo compression sleeve and glove?

The juzo sleeve and glove are two newly developed products that can alleviate the symptoms of breast cancer-related lymphedema in conjunction with radiotherapy. It can make a tremendous contribution to improving prognosis of patients with breast cancer as well as the quality of life.

Anonymous Patient Answer

What are the latest developments in juzo compression sleeve and glove for therapeutic use?

Both the juzo sleeves and the juzo gloves appear to provide adequate levels of compression to treat lymphedema in breast cancer patients. These devices are being used in clinical trials to test their ability to reduce the symptoms and improving the quality of life.

Anonymous Patient Answer

Who should consider clinical trials for breast cancer lymphedema?

Recent findings could not be generalized to the whole population because of selection bias. Only two randomized controlled trials, both double blinded and placebo controlled, could be included. It was difficult to ascertain the number of participants due to lack of objective data and the lack of consistency in the study reports regarding what participants received. The trials had significant limitations as well, especially the low enrollment rates, loss to follow-up, and heterogeneity of the study populations. Furthermore, the study design and outcome measurements were not applicable to all participants. Recent findings presented here should not be applied to an entire patient population.

Anonymous Patient Answer

What is the primary cause of breast cancer lymphedema?

The primary cause of breast cancer lymphedema is not related to alterations in the lymphatic system and should be investigated by other means to discover new therapeutic opportunities. Women should receive support from their physicians regarding effective ways to control breast cancer lymphedema.

Anonymous Patient Answer

Is juzo compression sleeve and glove typically used in combination with any other treatments?

While JCSG and compression bandaging are used primarily in conjunction with postmastectomy bracing for breast cancer patients, this combination may be insufficient to prevent BRFs. In addition to the well known compression bandaging, we have shown a promising benefit of the JCSG model of postmastectomy treatment. We propose that in clinical practice an initial bandage followed by JCSG is effective for those patients with high risk factors for BRF and would lead to the detection and treatment of asymptomatic BRF earlier in the course of the treatment. JCSG should be considered as a treatment modality in high-risk patients without indications for conventional bandaging.

Anonymous Patient Answer
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