LymphedemaNCT06374745
An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
An observational study of Lymphedema and Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphedema, Breast Cancer
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2015to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with lymphedema surgery performed at the University Hospital Basel between 2015 and 2023.
Who may be able to join
- status post breast cancer or status post another type of cancer or status post no cancer
- chronic lymphedema - lymphedema lasting over three months - present prior to surgical treatment
- one type of surgical procedure for treatment of chronic lymphedema or a combination of surgical procedures for treatment of chronic lymphedema was performed
- one or any combination of the following surgical procedures was used in each individual patient: Lymph Node-Vein Anastomosis (LNVA) , Lymphaticovenous Anastomosis (LVA), Tumescent Liposuction (TL), Vascularized Lymph Node Transfer (VLNT) and/or Water-Assisted Liposuction (WAL)
- loss to follow-up (data not successfully collected)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Elisabeth A Kappos, PD Dr. med., 0041 61 265 25 25, elisabeth.kappos@usb.ch
Adriano Fabi, BMed, 0041 79 888 12 51, adriano.fabi@uzh.ch
About this study
The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema.
Read the detailed description
Evidence-based surgical treatment recommendations for lymphedema post breast cancer surgery are practically non-existent. In fact, the meager literature on this matter takes into account only quality of life or patient reported outcome - if at all. In light of the heavy burden imposed upon a large portion of breast cancer survivors by chronic lymphedema, the investigators' study aims to create an evidence-based treatment protocol - "The Basel Lymphedema Protocol" - to guide surgeons in taking the best course of action when advising patients, engaging in shared-decision and performing surgery to reduce lymphedema post breast cancer treatment. Accordingly, one of the investigators' driving goals is to allow surgeons to one day be able consistently rely on hard data.
This study is ultimately based on the investigators' intent to further patient welfare. To this effect, creating an integrated algorithm based on concrete, tangible data will not only aid patients by leading to improved treatment of their chronic lymphedema and enabling higher quality of life, but it will also bolster access to adequate coverage. For at present, surgical treatment of lymphedema requires submitting a request for a commitment to cover costs to health insurance providers. This is a protracted, tedious and - unfortunately - an oftentimes fruitless endeavour. However, by having a strong factual basis - more scientific data and peer-reviewed studies - such requests gain a much greater chance of success. To this end, the current study certainly has the capacity to pave the way and set evidence-based standards. And lastly, the creation and implementation of "The Basel Lymphedema Protocol" would strongly reflect the tenets and purpose of personalized/precision medicine - treatment tailored to the unique patient - and by so doing, refine resource allocation and cost-effectiveness of the healthcare system.
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Post-surgical Treatment, Chronic Lymphedema Treatment
- Medical subject headings
- Lymphedema, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery.
To design an integrated algorithm for surgical treatment of chronic cancer-associated lymphedema using the following variables captured in Primary Outcomes 2 to 21.
Measured: baseline to follow up (no later than December 2024)
Date of follow-up procedure
Date of follow-up procedure.
Measured: baseline to follow up (no later than December 2024)
Follow-up and type of lymphedema surgery
If applicable, follow-up and type of lymphedema surgery
Measured: baseline to follow up (no later than December 2024)
Circumferences of the affected and unaffected side
Circumferences of the affected and unaffected side preoperatively and at postoperative time points.
Measured: baseline to follow up (no later than December 2024)
Postoperative complications
Postoperative complications
Measured: baseline to follow up (no later than December 2024)
Surgery duration.
Surgery duration in minutes.
Measured: baseline to follow up (no later than December 2024)
Type of lymphedema surgery
Type of lymphedema surgery including number of anastomoses, localization, long-term patency.
Measured: baseline to follow up (no later than December 2024)
Date of lymphedema surgery
Date of lymphedema surgery.
Measured: baseline to follow up (no later than December 2024)
Use of compression stockings
Use of compression stockings
Measured: baseline to follow up (no later than December 2024)
Number of lymphedema drainages per week
Number of lymphedema drainages per week.
Measured: baseline to follow up (no later than December 2024)
Stage of lymphedema
Stage of lymphedema (stage I, II or III)
Measured: baseline to follow up (no later than December 2024)
Duration of lymphedema
Duration of lymphedema.
Measured: baseline to follow up (no later than December 2024)
Location of lymphedema
Location of lymphedema.
Measured: baseline to follow up (no later than December 2024)
Subsequent cancer treatment
Subsequent cancer treatment (Chemotherapy, Radiotherapy)
Measured: baseline to follow up (no later than December 2024)
Date of cancer related surgery
Date of cancer related surgery
Measured: baseline to follow up (no later than December 2024)
Tumor staging
Tumor staging, considering the following parameters: tumor node metastasis (TNM), resection status of the cancerous growth (R), lymphatic vessel invasion by cancerous cells (L), venous invasion by cancerous cells (V) and grade of cancer cells (G).
Measured: baseline to follow up (no later than December 2024)
Tumor location
Tumor location (right, left, both sides).
Measured: baseline to follow up (no later than December 2024)
BMI
Patient's BMI in kg/m2.
Measured: baseline to follow up (no later than December 2024)
Comorbidities
Existence of comorbidities.
Measured: baseline to follow up (no later than December 2024)
Age
Patient's age in years.
Measured: baseline to follow up (no later than December 2024)
Gender
Patient's gender, given the possibilities male or female.
Measured: baseline to follow up (no later than December 2024)
Secondary outcomes (6)
Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema
Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema
Measured: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer
Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer
Measured: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history
Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history
Measured: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history
Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history
Measured: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS
Analysis of cohort subgroups: all patients who underwent Deep Inferior Epigastric Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap or Latissimus Dorsi Myocutaneous (LDM) flap or implant based breast reconstruction or Breast Conserving Surgery (BCS)
Measured: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: exploratory
Analysis of cohort subgroups: exploratory
Measured: baseline to follow up (no later than December 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start2 Jan 2015
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Sana Kliniken Düsseldorf GmbH
- Responsible party
- Sponsor
- Investigators
- Elisabeth A Kappos, PD Dr. med, Principal investigator, USB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374745
- Sponsor's protocol ID
- 2020-01307; mu24Kappos
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
- ClinicalTrials.gov ID
- NCT06374745
- Acronym / sponsor ID
- 2020-01307; mu24Kappos
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Post-surgical Treatment, Chronic Lymphedema Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Sana Kliniken Düsseldorf GmbH
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema.
Detailed description
Evidence-based surgical treatment recommendations for lymphedema post breast cancer surgery are practically non-existent. In fact, the meager literature on this matter takes into account only quality of life or patient reported outcome - if at all. In light of the heavy burden imposed upon a large portion of breast cancer survivors by chronic lymphedema, the investigators' study aims to create an evidence-based treatment protocol - "The Basel Lymphedema Protocol" - to guide surgeons in taking the best course of action when advising patients, engaging in shared-decision and performing surgery to reduce lymphedema post breast cancer treatment. Accordingly, one of the investigators' driving goals is to allow surgeons to one day be able consistently rely on hard data.
This study is ultimately based on the investigators' intent to further patient welfare. To this effect, creating an integrated algorithm based on concrete, tangible data will not only aid patients by leading to improved treatment of their chronic lymphedema and enabling higher quality of life, but it will also bolster access to adequate coverage. For at present, surgical treatment of lymphedema requires submitting a request for a commitment to cover costs to health insurance providers. This is a protracted, tedious and - unfortunately - an oftentimes fruitless endeavour. However, by having a strong factual basis - more scientific data and peer-reviewed studies - such requests gain a much greater chance of success. To this end, the current study certainly has the capacity to pave the way and set evidence-based standards. And lastly, the creation and implementation of "The Basel Lymphedema Protocol" would strongly reflect the tenets and purpose of personalized/precision medicine - treatment tailored to the unique patient - and by so doing, refine resource allocation and cost-effectiveness of the healthcare system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with lymphedema surgery performed at the University Hospital Basel between 2015 and 2023.
Key inclusion criteria (5 listed)
- status post breast cancer or status post another type of cancer or status post no cancer
- chronic lymphedema - lymphedema lasting over three months - present prior to surgical treatment
- one type of surgical procedure for treatment of chronic lymphedema or a combination of surgical procedures for treatment of chronic lymphedema was performed
- one or any combination of the following surgical procedures was used in each individual patient: Lymph Node-Vein Anastomosis (LNVA) , Lymphaticovenous Anastomosis (LVA), Tumescent Liposuction (TL), Vascularized Lymph Node Transfer (VLNT) and/or Water-Assisted Liposuction (WAL)
- loss to follow-up (data not successfully collected)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery.
Time frame: baseline to follow up (no later than December 2024)
To design an integrated algorithm for surgical treatment of chronic cancer-associated lymphedema using the following variables captured in Primary Outcomes 2 to 21.
Date of follow-up procedure
Time frame: baseline to follow up (no later than December 2024)
Date of follow-up procedure.
Follow-up and type of lymphedema surgery
Time frame: baseline to follow up (no later than December 2024)
If applicable, follow-up and type of lymphedema surgery
Circumferences of the affected and unaffected side
Time frame: baseline to follow up (no later than December 2024)
Circumferences of the affected and unaffected side preoperatively and at postoperative time points.
Postoperative complications
Time frame: baseline to follow up (no later than December 2024)
Postoperative complications
Surgery duration.
Time frame: baseline to follow up (no later than December 2024)
Surgery duration in minutes.
Type of lymphedema surgery
Time frame: baseline to follow up (no later than December 2024)
Type of lymphedema surgery including number of anastomoses, localization, long-term patency.
Date of lymphedema surgery
Time frame: baseline to follow up (no later than December 2024)
Date of lymphedema surgery.
Use of compression stockings
Time frame: baseline to follow up (no later than December 2024)
Use of compression stockings
Number of lymphedema drainages per week
Time frame: baseline to follow up (no later than December 2024)
Number of lymphedema drainages per week.
Stage of lymphedema
Time frame: baseline to follow up (no later than December 2024)
Stage of lymphedema (stage I, II or III)
Duration of lymphedema
Time frame: baseline to follow up (no later than December 2024)
Duration of lymphedema.
Location of lymphedema
Time frame: baseline to follow up (no later than December 2024)
Location of lymphedema.
Subsequent cancer treatment
Time frame: baseline to follow up (no later than December 2024)
Subsequent cancer treatment (Chemotherapy, Radiotherapy)
Date of cancer related surgery
Time frame: baseline to follow up (no later than December 2024)
Date of cancer related surgery
Tumor staging
Time frame: baseline to follow up (no later than December 2024)
Tumor staging, considering the following parameters: tumor node metastasis (TNM), resection status of the cancerous growth (R), lymphatic vessel invasion by cancerous cells (L), venous invasion by cancerous cells (V) and grade of cancer cells (G).
Tumor location
Time frame: baseline to follow up (no later than December 2024)
Tumor location (right, left, both sides).
BMI
Time frame: baseline to follow up (no later than December 2024)
Patient's BMI in kg/m2.
Comorbidities
Time frame: baseline to follow up (no later than December 2024)
Existence of comorbidities.
Age
Time frame: baseline to follow up (no later than December 2024)
Patient's age in years.
Gender
Time frame: baseline to follow up (no later than December 2024)
Patient's gender, given the possibilities male or female.
6 secondary outcomes
Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema
Time frame: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer
Time frame: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history
Time frame: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history
Time frame: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS
Time frame: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: exploratory
Time frame: baseline to follow up (no later than December 2024)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisabeth A Kappos, PD Dr. med principal investigator
USB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth A Kappos, PD Dr. med (0041 61 265 25 25, elisabeth.kappos@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. (time frame: baseline to follow up (no later than December 2024)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.