Research with human participants

Overview of medical research in the Netherlands

The First Bratelle study, a prospective, single-arm, pilot study to confirm the efficacy of the Bratelle breast-pads, that has been experienced by a small group of individual patients, in a larger group and in a controlled setting.

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Last updated:

Primary, improvement of the quality of life.Secondary, reduction of pain and a decrease of the number of treatments by a breast oedema therapist.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Injuries by physical agents
Study type
Interventional

ID

NL-OMON48727

Source

ToetsingOnline

Brief title

FILLE study

Condition

  • Injuries by physical agents
  • Skin and subcutaneous tissue disorders NEC
  • Lymphatic vessel disorders

Synonym

'breast edema', 'fluid in a breast'

Research involving

Human

Sponsors and support

Primary sponsor :
Meander Medisch Centrum
Source(s) of monetary or material Support :
Didert B.V.,Financiering door de sponsor en vanuit bedrijven.,Lacidem,Lohmann & Rauscher

Intervention

Keyword :
Bratelle, Breast, Cancer, Oedema

Outcome measures

Primary outcome

Improvement of the Quality of Life score assessed using the EORTC QLQ-CR30 en

QLQ-BR23 questionnaires.

Secondary outcome

Improvement of the Pain NRS.

Reduction of the number of necessary treatments by a breast oedema therapist

Background summary

Use of the Bratelle breast-pads by a few, individual patients has resulted in
an improvement of symptoms resulting from breast oedema. The Fille study aims
to confirm this anecdotal efficacy in a larger group of patients, 30 in total,
in a controlled setting.

Study objective

Primary, improvement of the quality of life.
Secondary, reduction of pain and a decrease of the number of treatments by a
breast oedema therapist.

Study design

Prospective, feasibility study

Intervention

The Bratelle breast-pads are used whenever the patient is wearing a bra for a
period of 3 months (study duration).

Study burden and risks

Participation in the Fille study is associated with a relative mild burden for
a period of 3 months. The Bratelle breast-pads can be easily positioned in the
bra and have a soft surface so that wearing the pads is not inconvenient or
painful.
There are no specific risks associated with the use of the Bratelle
breast-pads.

Public
Meander Medisch Centrum

Maatweg 3 3
Amersfoort 3813 TZ
NL
Scientific
Meander Medisch Centrum

Maatweg 3 3
Amersfoort 3813 TZ
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Female with breast edema, existing for more than 1 year, as a result of
treatment for breast cancer with breast conserving surgery and radiotherapy.

Exclusion criteria

Ongoing radiotherapy, open skin lesions and not able to wear the Bratelle
breast-pads, previous treatment with the Bratelle.

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
30
Type :
Actual

Medical products/devices used

Generic name :
Komprex II
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

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 NL64992.100.19