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Breast edema after breast-conserving surgery and radiotherapy

Breast edema after breast-conserving surgery and radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23137
Enrollment
200
Registered
2017-03-17
Start date
2017-03-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

In contrast to arm morbidity which is thoroughly described in literature, only a few studies investigated breast morbidity after breast cancer treatment. Currently, there is no consensus on the definition of breast edema and on standardized assessment criteria. Common criteria found in literature are an increased volume of the breast, peau d’orange, heaviness of the breast, redness of the skin, breast pain, skin thickening, hyperpigmented skin pores and a positive pitting sign.

Interventions

Patients who underwent breast-conserving surgery in one of the hospitals of the Iridium network, report in the St. Augustinus Hospital to the Radiotherapy Department for a simulation. Patients are inf

Sponsors

Faculty of Medicine and Health Sciences, department of rehabilitation sciences and physiotherapy, MOVANT research group, Universiteitsplein 1, 2610 Wilrijk, Belgium
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Women - Unilateral breast-conserving surgery - Radiotherapy - Between 18 and 65 years old

Exclusion criteria

Exclusion criteria: - Only mammotome biopsies - Other disorders which can cause breast edema - Plastic surgery such as mammoplasty in patients with macromastia - Pregnany - Lack of understanding of the Dutch language

Design outcomes

Primary

MeasureTime frame
The breast edema questionnaire consists of 2 parts. In the first part, symptoms of breast edema such as described in literature are scored on a scale from 0 to 10: pain, heaviness, swelling, tensed skin, redness, pitting sign, enlarged skin pores and hardness. Taking into account the ICF (International Classification of Functioning, disabilities and health), a number of activities and participations are scored on a scale from 0 to 10. This is part 2 of the questionnaire. In both parts a higher score means more problems related to breast edema.

Secondary

MeasureTime frame
The McGill Quality of Life Questionnaire is used to assess the impact of breast edema on the quality of life.

Contacts

Public ContactNick Gebruers

University of Antwerp Universiteitsplein 1

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)