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.

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. - FILLE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48727

Enrollment

Registered

2020-01-20

Start date

2021-04-03

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'breast edema' 'fluid in a breast'

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Improvement of the Quality of Life score assessed using the EORTC QLQ-CR30 en QLQ-BR23 questionnaires.	—

Secondary

Measure	Time frame
Improvement of the Pain NRS. Reduction of the number of necessary treatments by a breast oedema therapist	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)