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.
ID
Source
Brief title
Condition
- Other condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Health condition
Borstoedeem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the course of patient reported pain over a 6 month period.
Secondary outcome
Secondary endpoints are the course of degree of breast edema and quality of
life over a 6 month period.
Background summary
Due to better treatment options and earlier detection of breast cancer,
survival rates continue to increase. As such, (late) treatment toxicity,
quality of life and cosmetic outcome are becoming more important. Treatment has
become less mutilating after breast conserving surgery combined with
whole-breast irradiation (i.e. breast conserving therapy (BCT)) became the
primary therapy for women with early stage breast cancer. However, an
increasingly common complication of BCT 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.
Study objective
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 design
A pilot study.
Intervention
Compression vest.
Study burden and risks
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).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53275.041.15 |