An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol

Breast Cancer Clinical Trial

Official title:

An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374745
• Other study ID #: 2020-01307; mu24Kappos
• Status: Recruiting
• Start date: January 2, 2015
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Elisabeth A Kappos, PD Dr. med
• Phone: 0041 61 265 25 25
• Email: elisabeth.kappos[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• inclusion criteria not met
• loss to follow-up (data not successfully collected)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Sana Kliniken Düsseldorf GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to follow up (no later than December 2024)
Primary	Date of follow-up procedure	Date of follow-up procedure.	baseline to follow up (no later than December 2024)
Primary	Follow-up and type of lymphedema surgery	If applicable, follow-up and type of lymphedema surgery	baseline to follow up (no later than December 2024)
Primary	Circumferences of the affected and unaffected side	Circumferences of the affected and unaffected side preoperatively and at postoperative time points.	baseline to follow up (no later than December 2024)
Primary	Postoperative complications	Postoperative complications	baseline to follow up (no later than December 2024)
Primary	Surgery duration.	Surgery duration in minutes.	baseline to follow up (no later than December 2024)
Primary	Type of lymphedema surgery	Type of lymphedema surgery including number of anastomoses, localization, long-term patency.	baseline to follow up (no later than December 2024)
Primary	Date of lymphedema surgery	Date of lymphedema surgery.	baseline to follow up (no later than December 2024)
Primary	Use of compression stockings	Use of compression stockings	baseline to follow up (no later than December 2024)
Primary	Number of lymphedema drainages per week	Number of lymphedema drainages per week.	baseline to follow up (no later than December 2024)
Primary	Stage of lymphedema	Stage of lymphedema (stage I, II or III)	baseline to follow up (no later than December 2024)
Primary	Duration of lymphedema	Duration of lymphedema.	baseline to follow up (no later than December 2024)
Primary	Location of lymphedema	Location of lymphedema.	baseline to follow up (no later than December 2024)
Primary	Subsequent cancer treatment	Subsequent cancer treatment (Chemotherapy, Radiotherapy)	baseline to follow up (no later than December 2024)
Primary	Date of cancer related surgery	Date of cancer related surgery	baseline to follow up (no later than December 2024)
Primary	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).	baseline to follow up (no later than December 2024)
Primary	Tumor location	Tumor location (right, left, both sides).	baseline to follow up (no later than December 2024)
Primary	BMI	Patient's BMI in kg/m2.	baseline to follow up (no later than December 2024)
Primary	Comorbidities	Existence of comorbidities.	baseline to follow up (no later than December 2024)
Primary	Age	Patient's age in years.	baseline to follow up (no later than December 2024)
Primary	Gender	Patient's gender, given the possibilities male or female.	baseline to follow up (no later than December 2024)
Secondary	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	baseline to follow up (no later than December 2024)
Secondary	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	baseline to follow up (no later than December 2024)
Secondary	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	baseline to follow up (no later than December 2024)
Secondary	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	baseline to follow up (no later than December 2024)
Secondary	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)	baseline to follow up (no later than December 2024)
Secondary	Analysis of cohort subgroups: exploratory	Analysis of cohort subgroups: exploratory	baseline to follow up (no later than December 2024)