Prospective Surveillance for Breast Cancer-Related Lymphedema (PROTECT)

• ClinicalTrials.gov Identifier: NCT04522648
• Recruitment Status: Recruiting
• First Posted: August 21, 2020
• Last Update Posted: February 24, 2021
• Sponsor: Rigshospitalet, Denmark
• Collaborators: Aarhus University Hospital; Odense University Hospital; Zealand University Hospital; Herlev Hospital
• Information provided by (Responsible Party): Bolette Rafn, Rigshospitalet, Denmark

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Other: Prospective surveillance	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
• Actual Study Start Date: January 4, 2021
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention (INT); 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; 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.
No Intervention: Control (CON); 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.

Outcome Measures

Primary Outcome Measures :

1. Prevalence of chronic lymphedema [ Time Frame: At 24 months post-surgery ]
   A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10

Secondary Outcome Measures :

1. Time-to-treatment [ Time Frame: INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery ]
   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
2. Health-related quality of life [ Time Frame: pre-treatment, 6, 12, 18 and 24 months post-surgery ]
   This will be measured by the EQ-5D questionnaire
3. Arm function [ Time Frame: pre-treatment, 6, 12, 18 and 24 months post-surgery ]
   This will be measured by the QuickDASH questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Contacts

Contact: Bolette S Rafn, PhD; +45 22913873; bolette.skjoedt.rafn@regionh.dk

Contact: Christoffer Johansen, Professor; +45 26169014; christoffer.johansen@regionh.dk

Locations

Denmark

Copenhagen University Hospital Rigshospitalet; Recruiting

Copenhagen, Denmark, 2100

Contact: Bolette Rafn

Herlev Hospital; Recruiting

Herlev, Denmark

Contact: Bolette Rafn

Odense University Hospital; Recruiting

Odense, Denmark

Contact: Bolette Rafn

Sponsors and Collaborators

Rigshospitalet, Denmark

Aarhus University Hospital

Odense University Hospital

Zealand University Hospital

Herlev Hospital

More Information

• Responsible Party: Bolette Rafn, Postdoc, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT04522648
• Other Study ID Numbers: PROTECT
• First Posted: August 21, 2020
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bolette Rafn, Rigshospitalet, Denmark:

lymphedema; Prospective surveillance

Additional relevant MeSH terms:

Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Lymphatic Diseases; Postoperative Complications; Pathologic Processes