Breast Edema Compression Vest

The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema; Edema; Breast Neoplasm
• Intervention / Treatment: Device: Compression vest, Thuasne

Detailed Description

In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating.

Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period.

Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: breast edema vest	Device: Compression vest, Thuasne; Wearing a compression 4 days/weel with a minumum of 6 hours per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of wearing a compression vest on degree of breast edema (CTCAE score)	During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.	At baseline
Effect of wearing a compression vest on degree of breast edema (CTCAE score)	During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.	At 1 month
Effect of wearing a compression vest on degree of breast edema (CTCAE score)	During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.	At 3 months
Effect of wearing a compression vest on degree of breast edema (CTCAE score)	During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.	At 6 months
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-C30 for quality of life and breast edema symptoms	At baseline
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-C30 for quality of life and breast edema symptoms	At 2 weeks after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-C30 for quality of life and breast edema symptoms	At 1 month after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-C30 for quality of life and breast edema symptoms	At 3 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-C30 for quality of life and breast edema symptoms	At 6 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-BR23 for quality of life and breast edema symptoms	At baseline
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-BR23 for quality of life and breast edema symptoms	At 2 weeks after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-BR23 for quality of life and breast edema symptoms	At 1 month after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-BR23 for quality of life and breast edema symptoms	At 3 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life	EORTC QLQ-BR23 for quality of life and breast edema symptoms	At 6 months after wearing a compression vest

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Thuasne

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema; Edema
• Other Study ID Numbers: NL53275.041.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED