Breast Edema Compression Vest

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627976
• Other study ID #: NL53275.041.15
• Status: Completed
• Phase: N/A
• First received: December 4, 2015
• Last updated: January 29, 2018
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms
• Edema
• Lymphedema

Intervention

Device:
• Compression vest, Thuasne
Wearing a compression 4 days/weel with a minumum of 6 hours per day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Thuasne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of wearing a compression vest on patient reported outcome pain	Brief Pain Inventory (BPI) for pain questionnaire	At baseline
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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