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
Summary description of the study
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 under investigation
Surgery for lymphedema
(BASEC)
Disease under investigation
chronic breast cancer-associated lymphedema
(BASEC)
Criteria for participation in trial
- 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)
Exclusion criteria
- 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)
Exclusion criteria
- 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)
Trial sites
Basel
(BASEC)
Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, Israel, Italy, Netherlands, Romania, Spain, Sweden, Switzerland, United States (ICTRP)
Sponsor
not available
Contact
Contact Person Switzerland
PD Dr. med Elisabeth Arthemis Kappos
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(BASEC)
General Information
University Hospital, Basel, Switzerland,
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(ICTRP)
Scientific Information
University Hospital, Basel, Switzerland,
+41 61 328 62 54
elisabeth.kappos@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
22.05.2023
(BASEC)
ICTRP Trial ID
NCT05890677 (ICTRP)
Official title (approved by ethics committee)
not available
Academic title
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)
Public title
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema (ICTRP)
Disease under investigation
Lymphedema, Breast Cancer (ICTRP)
Intervention under investigation
Procedure: Surgical Intervention;Procedure: Conservative Complex Physical Decongestion Therapy (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Swiss National Science Foundation;Rising Tide Foundation;Krebsforschung Schweiz, Bern, Switzerland (ICTRP)
Additional contacts
Elisabeth Kappos, Prof. Dr.;Elisabeth Kappos, Prof. Dr., elisabeth.kappos@usb.ch, +41 61 328 62 54, University Hospital, Basel, Switzerland, (ICTRP)
Secondary trial IDs
2023-00733, mu21kappos (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05890677 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available