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van CCT (UK)

van CCT (UK)

Breast edema after breast-conserving surgery and radiotherapy

- candidate number26916
- NTR NumberNTR6527
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2017
- Secondary IDsB300201317503 Ethical Comite of the University Hospital of Antwerp
- Public TitleBreast edema after breast-conserving surgery and radiotherapy
- Scientific TitleBreast edema after breast-conserving surgery and radiotherapy
- hypothesisBreast-conserving surgery followed by radiotherapy is a safe and effective procedure to treat early stage breast cancer. In many women, this type of treatment gives beside a good survival a good cosmetic result. However, some women will be troubled by breast edema. Breast edema causes a great discomfort during activities of daily living and has a negative impact on quality of life. Although breast edema is a common, debilitating complication of breast-conserving surgery, it is still strongly underrecognized in clinical practice.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Breast conserving surgery, Edema
- Inclusion criteria- Women
- Unilateral breast-conserving surgery
- Radiotherapy
- Between 18 and 65 years old
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-mrt-2017
- planned closingdate31-dec-2018
- Target number of participants200
- InterventionsPatients 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 informed about the study. If they wish to participate they are asked to fill out a consent form. During this first contact, the patient fills out the breast edema questionnaire and the Mc Gill Quality of Life questionnaire. Afterwards, the same questionnaires were sent by mail at fixed intervals: after the completion of radiation therapy and 3 months, 6 months and 12 months after radiotherapy. A stamped envelope is also sent, so the patient can return the completed questionnaire.
- Primary outcomeThe 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 outcomeThe McGill Quality of Life Questionnaire is used to assess the impact of breast edema on the quality of life.
- TimepointsBefore radiotherapy, after radiotherapy, 3 months, 6 months and 12 months after radiotherapy
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESprof. dr. Nick Gebruers
- CONTACT for SCIENTIFIC QUERIESprof. dr. Nick Gebruers
- Sponsor/Initiator Faculty of Medicine and Health Sciences, department of rehabilitation sciences and physiotherapy, MOVANT research group
- Funding
(Source(s) of Monetary or Material Support)
Faculty of Medicine and Health Sciences, department of rehabilitation sciences and physiotherapy, MOVANT research group
- Publications
- Brief summaryThe aim of the project is to prospectively assess the incidence and time path of breast edema in patients that are treated with breast conserving surgery in combination with radiotherapy. Additionally, the impact of breast edema on physical functioning (ICF-framework) and QoL will be investigated. Breast cancer patients will be recruited from the Iridium-network at the moment the simulation for radiotherapy is planned. Next, the patients are assessed prospectively: 1) at the end of radiotherapy (after last session), 2) every 3 months until 18 months of follow-up is established. The primary outcome measures are incidence of breast edema based upon a breast edema questionnaire and QoL by means of the Dutch McGill-QoL qiuestionnaire. Secondary, medical data will be related to the development of breast edema.
- Main changes (audit trail)
- RECORD17-mrt-2017 - 14-jul-2017

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