The LYMPH study – Surgical compared to "non-surgical" treatment of chronic lymphedema after breast cancer therapy

Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, Israel, Italy, Netherlands, Romania, Spain, Sweden, Switzerland, United States (ICTRP)

ID di studio ICTRP
NCT05890677 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
non disponibile

Titolo accademico
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)

Titolo pubblico
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema (ICTRP)

Malattie studiate
Lymphedema, Breast Cancer (ICTRP)

Intervento studiato
Procedure: Surgical Intervention;Procedure: Conservative Complex Physical Decongestion Therapy (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Swiss National Science Foundation;Rising Tide Foundation;Krebsforschung Schweiz, Bern, Switzerland (ICTRP)

Contatti aggiuntivi
Elisabeth Kappos, Prof. Dr.;Elisabeth Kappos, Prof. Dr., elisabeth.kappos@usb.ch, +41 61 328 62 54, University Hospital, Basel, Switzerland, (ICTRP)

ID secondari
2023-00733, mu21kappos (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05890677 (ICTRP)