Clinical trial NCT05326165: Early Intervention
Official title: Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Treatment Related Lymphedema
Keywords: Breast Cancer
Breast Cancer Treatment Related Lymphedema
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Heinz Family Foundation
name: Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema
name: Olayan-Xefos Family Fund for Breast Cancer Research
First posted: 2022-04-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: This is a single arm pilot study of a compression sleeve intervention for patients at high risk of breast cancer-related lymphedema (BCRL). The compression sleeve will also include a novel sensor to capture patient adherence to compression wear and pressure applied to the arm.

This research is being done because patients receiving lymph node surgery and lymph node radiation for breast cancer are at risk of lymphedema on the arm, trunk or breast/chest wall on the side of treatment. There is some evidence that compression sleeves may prevent progression of early swelling to lymphedema. This study is looking to determine if:

1. a compression garment worn for four weeks helps to prevent breast cancer-related lymphedema (BCRL) in those at high risk of BCRL
2. a sensor attached to the sleeve is accurately measuring time worn and pressure applied
3. participants are wearing the compression for the prescribed time, and if not, what are the barriers to wear
4. participants adhere to the study schedule for filling out patient surveys regarding symptoms and satisfaction with screening.

Findings from this study will apply to the development of a larger randomized controlled trial to examine if compression prevents progression to BCRL for patients with low volume swelling.

Study procedures include screening for eligibility, treatment including evaluations and follow up visits. Study treatment will last for four weeks with follow up at one, three, six, nine and 12 months.

It is expected that about 40 people will take part in this research study.

This study is receiving financial support from the Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema (AG Taghian); the Olayan-Xefos Family Fund for Breast Cancer Research (AG Taghian), and the Heinz Family Foundation (AGTaghian).

Juzo Inc. is supporting this research study by providing compression garments and a Juzo pressure monitor. Impedimed Inc is supporting this study by providing a Sozo bioimpedance measurement device for research use.

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.

Primary outcomes:
measure: Arm Volume
timeFrame: 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Sensor Accuracy
timeFrame: 4 Weeks
measure: Adherence rate to compression
timeFrame: 4 Weeks
measure: Questionnaire Completion
timeFrame: 1, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alphonse G Taghian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: