Health TrialsbyHealthPanel

Early Intervention

ConditionsBreast CancerBreast Cancer Treatment Related Lymphedema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Juzo Compression Sleeve and Glove

    Device

    Elasticized garment sized for arm and hand to create pressure to reduce swelling

  • Compression Sleeve Sensor

    Device

    Small device embedded within compression sleeve garment collecting usage information

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Compression therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Arm Volume

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) .

Time frame
1, 3, 6, 9 and 12 months

Secondary outcomes

1

Sensor Accuracy

Accuracy will be defined as sensor-detected wear within ±4.17% of true wear

Time frame
4 Weeks
2

Adherence rate to compression

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),

Time frame
4 Weeks
3

Questionnaire Completion

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.

Time frame
1, 3, 6, 9 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Heinz Family Foundation

Collaborator

Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema

Collaborator

Olayan-Xefos Family Fund for Breast Cancer Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: