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Prospective Surveillance for Breast Cancer-Related Lymphedema (PROTECT)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prospective surveillance
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring lymphedema, Prospective surveillance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Copenhagen University Hospital RigshospitaletRecruiting
  • Herlev HospitalRecruiting
  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (INT)

Control (CON)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prevalence of chronic lymphedema
A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10

Secondary Outcome Measures

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
Health-related quality of life
This will be measured by the EQ-5D questionnaire
Arm function
This will be measured by the QuickDASH questionnaire

Full Information

First Posted
August 18, 2020
Last Updated
August 16, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04522648
Brief Title
Prospective Surveillance for Breast Cancer-Related Lymphedema
Acronym
PROTECT
Official Title
Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
lymphedema, Prospective surveillance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (INT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (CON)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prospective surveillance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of chronic lymphedema
Description
A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10
Time Frame
At 24 months post-surgery
Secondary Outcome Measure Information:
Title
Time-to-treatment
Description
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
Time Frame
INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery
Title
Health-related quality of life
Description
This will be measured by the EQ-5D questionnaire
Time Frame
pre-treatment, 6, 12, 18 and 24 months post-surgery
Title
Arm function
Description
This will be measured by the QuickDASH questionnaire
Time Frame
pre-treatment, 6, 12, 18 and 24 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bolette S Rafn, PhD
Phone
+45 22913873
Email
bolette.skjoedt.rafn@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Christoffer Johansen, Professor
Phone
+45 26169014
Email
christoffer.johansen@regionh.dk
Facility Information:
Facility Name
Copenhagen University Hospital Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bolette Rafn
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bolette Rafn
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bolette Rafn

12. IPD Sharing Statement

Plan to Share IPD
No

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Prospective Surveillance for Breast Cancer-Related Lymphedema

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