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Early Intervention

Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study treatment will last for four weeks with follow up at one, three, six, nine and 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests a compression sleeve with a built-in sensor to prevent lymphedema, or swelling caused by a buildup of lymph fluid. It is for adult women with mild arm swelling after breast cancer surgery that removed underarm lymph nodes.

This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older who had breast cancer surgery and removal of a group of underarm lymph nodes on the cancer side.
  • Mild arm swelling, with a 5% to less than 10% increase in arm size, at least 12 weeks after surgery.
  • Able to read and understand English, understand the study, and willing to sign a consent form.
  • A preventive sentinel lymph node biopsy on the other side is allowed. This removes a few lymph nodes to check for cancer.

Who can't join

  • Breast cancer in both breasts, with lymph nodes checked or removed on both sides.
  • Already diagnosed with or treated for arm swelling caused by lymph fluid buildup after breast cancer.
  • Cancer that has spread to other parts of the body.
  • Only a sentinel lymph node biopsy, rather than removal of a larger group of underarm lymph nodes, on the cancer side.
  • People who are pregnant or have an implanted heart device cannot take part in the Sozo measurement part of the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Eligible participants will be female, \>/= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included. * Eligible participants will demonstrate low volume swelling (RVC 5-\<10%) \>/=12 weeks postoperatively * Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document. * Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and/or regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC. Exclusion Criteria: * Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation. * Participants will not be eligible if they have been diagnosed and/or treated for BCRL. * Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded. * Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.

Study sites (1)

MA