Brief description of trial (Data source: BASEC)
Die Studie untersucht, ob die chirurgische Behandlung von chronischem Brustkrebs-assoziierten Lymphödem die Lebensqualität der TeilnehmerInnen im Vergleich zur alleinigen konservativen Therapie verbessert.
Health conditions investigated(Data source: BASEC)
chronisches Burstkrebs-assoziiertes Lymphödem
Health conditions
(Data source: WHO)
Lymphedema, Breast Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Operation des Lymphödems
Interventions
(Data source: WHO)
Procedure: Surgical Intervention;Procedure: Conservative Complex Physical Decongestion Therapy
Criteria for participation in trial
(Data source: BASEC)
- Schriftliche Einverständniserklärung.
- Patientinnen/Patienten ≥ 18 Jahre mit vorheriger Behandlung von Brustkrebs.
- Mindestens eine der folgenden vorherigen Brustkrebsbehandlungen: Entnahme einer Gewebeprobe des Lymphknotens, Lymphknotenentfernung der Achselhöhle, Strahlentherapie der Brustwand oder Achselhöhle oder Brustkrebsoperation.
Exclusion criteria
(Data source: BASEC)
- Keine Indikation zur Lymphoperation nach klinischer Einschätzung des behandelnden Operateurs
- Primär angeborenes Lymphödem oder nicht brustkrebsinduziertes Lymphödem
- Notwendigkeit einer sofortigen Lymphödem-Operation nach klinischem Urteil eines Spezialisten aufgrund eines fortgeschrittenen Stadiums, das eine lymphatische Rekonstruktion unmöglich macht
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Written informed consent.
- Patients = 18 years of age.
- Previous diagnosis of breast cancer.
- Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) as defined by
the international society of lymphology (inter-limb difference of >10% in volume or
excess volume between the affected and non-affected limbs present for more than 3
months).
- Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
- Ability to complete the QoL questionnaires.
Exclusion Criteria:
- No indication for lymphatic surgery according to clinical judgment of the treating
surgeon (individual reasons will be specifically documented).
- Primary congenital Lymphedema or non-BCRL.
- Previous surgical BCRL treatment.
-
Further information on trial
Recruitment status
Recruiting
Academic title
(Data source: WHO)
The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Change in Quality of Life Questionnaire (Lymph-ICF-UL)
Secundary end point
(Data source: WHO)
Change in Quality of Life Questionnaire (Lymph-ICF-UL);Change in Quality of Life Questionnaire (LYMPH-Q);Change in Quality of Life Questionnaire (EuroQol EQ-5D-5L);Change in Pain score (visual analog scale);Assessment of (serious) adverse events;Assessment of surgical complications;Assessment of lymphangitic events (erysipelas);Assessment of arm volume;Assessment of the frequency of lymphatic drainage;Assessment of the burden on patients;Assessment of the economics (for Switzerland)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, Italy, Netherlands, Romania, Spain, Sweden, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. med Elisabeth Arthemis Kappos
+41 61 328 62 54
elisabeth.kappos@usb.ch
Contact for general information
(Data source: WHO)
Elisabeth Kappos, Prof. Dr.
University Hospital, Basel, Switzerland
+41 61 328 62 54
elisabeth.kappos@usb.ch
Contact for scientific information
(Data source: WHO)
Elisabeth Kappos, Prof. Dr.
University Hospital, Basel, Switzerland
+41 61 328 62 54
elisabeth.kappos@usb.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
22.05.2023
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2023-00733
Secondary ID (Data source: WHO)
mu21kappos
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