Breast Edema Compression Vest

NCT ID: NCT02627976

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-01-31

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.

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).

Conditions

Edema; Lymphedema; Breast Neoplasm; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

breast edema vest

Group Type: ACTIVE_COMPARATOR

Compression vest, Thuasne

Intervention Type: DEVICE

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

Interventions

Compression vest, Thuasne

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thuasne

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

M.L. Gregorowitsch

MD, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NL53275.041.15

Identifier Type: -

Identifier Source: org_study_id