Early Intervention
Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study
1 other identifier
interventional
40
1 country
1
Brief Summary
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started May 2026
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 6, 2026
May 1, 2026
1.2 years
April 6, 2022
May 4, 2026
Conditions
Keywords
Outcome Measures
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) .
1, 3, 6, 9 and 12 months
Secondary Outcomes (3)
Sensor Accuracy
4 Weeks
Adherence rate to compression
4 Weeks
Questionnaire Completion
1, 3, 6, 9 and 12 months
Study Arms (1)
Compression therapy
EXPERIMENTALParticipants will receive a ready to wear compression sleeve and glove with embedded sensor. Compression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks. Participants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.
Interventions
Elasticized garment sized for arm and hand to create pressure to reduce swelling
Small device embedded within compression sleeve garment collecting usage information
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alphonse G Taghian, MD, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2022
First Posted
April 13, 2022
Study Start
May 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.