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SNCTP000005537 | NCT05890677 | BASEC2023-00733

Die LYMPH-Studie – Operative im Vergleich zur “nicht operativen” Behandlung von chronischem Lymphödem nach Brustkrebstherapie

Data source: BASEC (Imported from 20.12.2024), WHO (Imported from 19.12.2024)
Changed: Dec 19, 2024, 1:00 AM
Disease category: Other, Surgery

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.

- Former diagnosis of breast cancer.

- Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting
for more than 3 months) classified as = Stage 1, according to ISL.

- Minimum of 3 months Conservative Complex Physical Decongestion Therapy.

- Ability to complete the QoL questionnaires.

- Willingness to undergo surgery.

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 on the side intended for intervention.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT05890677

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05890677
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: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

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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