NCT02187289

Brief Summary

Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

July 9, 2014

Last Update Submit

February 18, 2021

Conditions

Breast CancerLymphedema

Keywords

NCSGCompression bandagesdevicesNight time compressionBreast cancer treatment side effectsCompression therapyReid SleeveComprefitMedassistTributeComprilan

Outcome Measures

Primary Outcomes (1)

  • Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)

    12 weeks

Secondary Outcomes (1)

  • Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm

    12 weeks

Study Arms (3)

Standard care

ACTIVE COMPARATOR

Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear)

Device: Compression Sleeve, daytime wear

Standard Care plus Night-time Compression Bandages

EXPERIMENTAL

Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.

Device: Night-time compression bandagesDevice: Compression Sleeve, daytime wear

Standard Care Plus Night-time Compression System Garment

EXPERIMENTAL

Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment

Device: Compression Sleeve, daytime wearDevice: Night-time Compression custom-made garment

Interventions

Night-time compression bandagesDEVICE

Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.

Standard Care plus Night-time Compression Bandages
Compression Sleeve, daytime wearDEVICE
Standard Care Plus Night-time Compression System GarmentStandard Care plus Night-time Compression BandagesStandard care
Night-time Compression custom-made garmentDEVICE

Standard Care plus night-time compression by a custom-made night time compression system garment.

Standard Care Plus Night-time Compression System Garment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
  • Completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
  • In or entering upon the maintenance phase of lymphedema treatment.
  • Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
  • No current use of night-time compression (one month wash-out period before trial entry)

You may not qualify if:

  • Clinical or radiological evidence of active disease, either local or metastatic
  • History or clinical diagnosis of bilateral arm lymphedema
  • Anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
  • Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
  • Unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Mount St. Joseph Hospital/Holy Family (MSJ/HF)

Vancouver, British Columbia, V5T 3N4, Canada

Location

Related Publications (2)

  • McNeely ML, Dolgoy ND, Rafn BS, Ghosh S, Ospina PA, Al Onazi MM, Radke L, Shular M, Kuusk U, Webster M, Campbell KL, Mackey JR. Nighttime compression supports improved self-management of breast cancer-related lymphedema: A multicenter randomized controlled trial. Cancer. 2022 Feb 1;128(3):587-596. doi: 10.1002/cncr.33943. Epub 2021 Oct 6.

    PMID: 34614195DERIVED

  • McNeely ML, Campbell KL, Webster M, Kuusk U, Tracey K, Mackey J. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial. BMC Cancer. 2016 Aug 4;16:601. doi: 10.1186/s12885-016-2648-8.

    PMID: 27491361DERIVED

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Margaret McNeely, PhD

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2017

Study Completion

November 1, 2019

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication will be available via the University of Alberta's DATAVERSE platform.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be available starting 6 months after publication with no defined end date.
Access Criteria
Guest book - visitors can request the data from corresponding author.
More information

Locations

CA(3)