Compression vest, Thuasne
DeviceWearing a compression 4 days/weel with a minumum of 6 hours per day
NCT Number: NCT02627976
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wearing a compression 4 days/weel with a minumum of 6 hours per day
Time frame: At baseline
Brief Pain Inventory (BPI) for pain questionnaire
Time frame: 2 weeks
Brief Pain Inventory (BPI) for pain questionnaire
Time frame: 1 month
Brief Pain Inventory (BPI) for pain questionnaire
Time frame: 3 months
Brief Pain Inventory (BPI) for pain questionnaire
Time frame: 6 months
Brief Pain Inventory (BPI) for pain questionnaire
Time frame: At baseline
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Time frame: At 1 month
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Time frame: At 3 months
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Time frame: At 6 months
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Time frame: At baseline
EORTC QLQ-C30 for quality of life and breast edema symptoms
Time frame: At 2 weeks after wearing a compression vest
EORTC QLQ-C30 for quality of life and breast edema symptoms
Time frame: At 1 month after wearing a compression vest
EORTC QLQ-C30 for quality of life and breast edema symptoms
Time frame: At 3 months after wearing a compression vest
EORTC QLQ-C30 for quality of life and breast edema symptoms
Time frame: At 6 months after wearing a compression vest
EORTC QLQ-C30 for quality of life and breast edema symptoms
Time frame: At baseline
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Time frame: At 2 weeks after wearing a compression vest
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Time frame: At 1 month after wearing a compression vest
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Time frame: At 3 months after wearing a compression vest
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Time frame: At 6 months after wearing a compression vest
EORTC QLQ-BR23 for quality of life and breast edema symptoms
UMC Utrecht
Other
The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05142800
Breast Cancer, Breast Cancer Lymphedema
Boston, Massachusetts, United States
View Trial DetailsNCT05628688
Chronic Venous Insufficiency, Edema
Oakland, California, United States
View Trial DetailsNCT06069908
Edema, Grip
Istanbul, Gaziosmanpaşa, Turkey (Türkiye)
View Trial DetailsNCT06220903
Edema, Hemic and Lymphatic Diseases
Istanbul, Beykoz, Turkey (Türkiye)
View Trial Details