Prospective Surveillance for Breast Cancer-Related Lymphedema

Study Overview
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Brief Summary
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This randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema.

Detailed Description
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Design and setting: This trial is a multi-center single-blind trial involving five hospitals in Denmark. Procedure: All women booked for surgery for breast cancer at one of the study sites will be invited to participate. Women, who provide written informed consent, will have BIS measurements, and perform self-measurements of arm circumference. Further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. This data will be collected at the hospital of surgery at pre-treatment. After surgery, women who had >6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.

Official Title
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Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Prospective surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female; ≥18 years; surgery for breast cancer (unilateral and bilateral) including ALDN with >6 lymph nodes removed; can effectively communicate verbally in Danish; Exclusion Criteria: surgery for breast cancer with SLNB or < 6 nodes removed; pre-existing lymphedema (primary or secondary); previous treatment for breast cancer; pace maker; conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (INT)<br>INT participants will be asked to perform self-measurements of arm circumference at five points along the arm at home every three months. Additional measurements can be performed if the participants experience signs of BCRL. Participants will report the self-measurements in cm and mm in an online questionnaire, or over the phone to a physiotherapist navigator, along with reporting sign and symptoms of BCRL. | Other: Prospective surveillance<br>* A participant with an increase from pre-surgery in total arm volume of ≥6% by self-measurement, or symptoms of BCRL ≥2 NRS will receive an assessment by a lymphedema therapist. At this appointment, participants will receive a physical examination of the arm along with a BIS measurement. A participant is considered having subclinical BCRL if an increase in lymphedema index (L-DEX) ≥7 from pre-surgery measured by BIS is identified. A fitted compression garment and gauntlet is then provided, free of charge, for daily wear 10 hours/day for four weeks along with a recommendation to use the arm for daily activities and maintain regular physical activity. Following the four-week compression period, participants will be re-measured using BIS to evaluate response. Participants who do not respond to compression will receive CDT delivered by the lymphedema therapist.<br>|
| No Intervention: Control (CON)<br>The CON group will follow the usual post-operative care. CON participants will be prompted every 6 months by an online questionnaire to report if they have been diagnosed with BCRL and if so, month of initiation of treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of chronic lymphedema | A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10 | At 24 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-treatment | INT group: The time (weeks) from surgery to first elevated L-DEX score which triggers immediate treatment along with time (weeks) to resolution of BCRL from diagnosis. For CON: time from surgery to BCRL diagnosis, time from diagnosis to BCRL treatment, and time from initiation to termination of treatment | INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery | 
| Health-related quality of life | This will be measured by the EQ-5D questionnaire | pre-treatment, 6, 12, 18 and 24 months post-surgery | 
| Arm function | This will be measured by the QuickDASH questionnaire | pre-treatment, 6, 12, 18 and 24 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, Prospective surveillance