NCT02627976

Brief Summary

A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies. The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

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

December 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

December 4, 2015

Last Update Submit

January 29, 2018

Conditions

EdemaLymphedemaBreast NeoplasmBreast Cancer

Outcome Measures

Primary Outcomes (5)

  • Effect of wearing a compression vest on patient reported outcome pain

    Brief Pain Inventory (BPI) for pain questionnaire

    At baseline

  • Effect of wearing a compression vest on patient reported outcome pain two weeks after wearing a compression vest

    Brief Pain Inventory (BPI) for pain questionnaire

    2 weeks

  • Effect of wearing a compression vest on patient reported outcome pain one month after wearing a compression vest

    Brief Pain Inventory (BPI) for pain questionnaire

    1 month

  • Effect of wearing a compression vest on patient reported outcome pain three months after wearing a compression vest

    Brief Pain Inventory (BPI) for pain questionnaire

    3 months

  • Effect of wearing a compression vest on patient reported outcome pain six months after wearing a compression vest

    Brief Pain Inventory (BPI) for pain questionnaire

    6 months

Secondary Outcomes (14)

  • Effect of wearing a compression vest on degree of breast edema (CTCAE score)

    At baseline

  • Effect of wearing a compression vest on degree of breast edema (CTCAE score)

    At 1 month

  • Effect of wearing a compression vest on degree of breast edema (CTCAE score)

    At 3 months

  • Effect of wearing a compression vest on degree of breast edema (CTCAE score)

    At 6 months

  • Effect of wearing a compression vest on patient reported quality of life

    At baseline

  • +9 more secondary outcomes

Study Arms (1)

breast edema vest

ACTIVE COMPARATOR
Device: Compression vest, Thuasne

Interventions

Compression vest, ThuasneDEVICE

Wearing a compression 4 days/weel with a minumum of 6 hours per day

breast edema vest

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females, aged 18 years and older.
  • Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain).
  • Visual Analog Scale (VAS) pain score of 3 or more.

You may not qualify if:

  • Inability to understand the Dutch language.
  • Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months.
  • Cardiac complaints.
  • Pacemaker.
  • Port-a-cath.
  • Thrombosis of the arm.
  • Pulmonary embolism.
  • Pulmonary disease.
  • Pregnancy.
  • Non-breast cancer related lymph edema.
  • Clinical depression or anxiety disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EdemaLymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsLymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 11, 2015

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01