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
Résumé de l'étude
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)
Intervention étudiée
Surgery for lymphedema
(BASEC)
Maladie en cours d'investigation
chronic breast cancer-associated lymphedema
(BASEC)
Critères de participation
- 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)
Critères d'exclusion
- 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)
Critères d'exclusion
- 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)
Lieu de l’étude
Bâle
(BASEC)
Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, Israel, Italy, Netherlands, Romania, Spain, Sweden, Switzerland, United States (ICTRP)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med Elisabeth Arthemis Kappos
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(BASEC)
Informations générales
University Hospital, Basel, Switzerland,
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(ICTRP)
Informations scientifiques
University Hospital, Basel, Switzerland,
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
22.05.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05890677 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
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)
Titre public
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema (ICTRP)
Maladie en cours d'investigation
Lymphedema, Breast Cancer (ICTRP)
Intervention étudiée
Procedure: Surgical Intervention;Procedure: Conservative Complex Physical Decongestion Therapy (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Swiss National Science Foundation;Rising Tide Foundation;Krebsforschung Schweiz, Bern, Switzerland (ICTRP)
Contacts supplémentaires
Elisabeth Kappos, Prof. Dr.;Elisabeth Kappos, Prof. Dr., elisabeth.kappos@usb.ch, +41 61 328 62 54, University Hospital, Basel, Switzerland, (ICTRP)
ID secondaires
2023-00733, mu21kappos (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05890677 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible