HumRes62881
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SNCTP000005537
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BASEC2023-00733
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NCT05890677
The LYMPH study – Surgical compared to "non-surgical" treatment of chronic lymphedema after breast cancer therapy
Zusammenfassung der Studie
The study investigates whether surgical treatment of chronic breast cancer-associated lymphedema improves the quality of life of participants compared to conservative therapy alone.
(BASEC)
Untersuchte Intervention
Surgery for lymphedema
(BASEC)
Untersuchte Krankheit(en)
chronic breast cancer-associated lymphedema
(BASEC)
Kriterien zur Teilnahme
- Written informed consent. - Patients ≥ 18 years with prior treatment for breast cancer. - At least one of the following prior breast cancer treatments: biopsy of the lymph node, axillary lymph node removal, radiation therapy of the chest wall or axilla, or breast cancer surgery. (BASEC)
Ausschlusskriterien
- No indication for lymph surgery according to the clinical assessment of the treating surgeon - Primary congenital lymphedema or non-breast cancer-induced lymphedema - Need for immediate lymphedema surgery according to the clinical judgment of a specialist due to an advanced stage that makes lymphatic reconstruction impossible (BASEC)
- Written informed consent. - Patients ≥ 18 years with prior treatment for breast cancer. - At least one of the following prior breast cancer treatments: biopsy of the lymph node, axillary lymph node removal, radiation therapy of the chest wall or axilla, or breast cancer surgery. (BASEC)
Ausschlusskriterien
- No indication for lymph surgery according to the clinical assessment of the treating surgeon - Primary congenital lymphedema or non-breast cancer-induced lymphedema - Need for immediate lymphedema surgery according to the clinical judgment of a specialist due to an advanced stage that makes lymphatic reconstruction impossible (BASEC)
Studienstandort
Basel
(BASEC)
Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, Israel, Italy, Netherlands, Romania, Spain, Sweden, Switzerland, United States (ICTRP)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med Elisabeth Arthemis Kappos
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(BASEC)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland,
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital, Basel, Switzerland,
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
22.05.2023
(BASEC)
ICTRP Studien-ID
NCT05890677 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial (ICTRP)
Öffentlicher Titel
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema (ICTRP)
Untersuchte Krankheit(en)
Lymphedema, Breast Cancer (ICTRP)
Untersuchte Intervention
Procedure: Surgical Intervention;Procedure: Conservative Complex Physical Decongestion Therapy (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change in Quality of Life Questionnaire (Lymph-ICF-UL) (ICTRP)
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) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Swiss National Science Foundation;Rising Tide Foundation;Krebsforschung Schweiz, Bern, Switzerland (ICTRP)
Weitere Kontakte
Elisabeth Kappos, Prof. Dr.;Elisabeth Kappos, Prof. Dr., elisabeth.kappos@usb.ch, +41 61 328 62 54, University Hospital, Basel, Switzerland, (ICTRP)
Sekundäre IDs
2023-00733, mu21kappos (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05890677 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar