JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT06374745

Studienbeginn:
Januar 2015

Letztes Update:
19.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms, Lymphedema

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
Sana Kliniken Düsseldorf GmbH

Studienleiter

Elisabeth A Kappos, PD Dr. med
Principal Investigator
USB

Kontakt

Elisabeth A Kappos, PD Dr. med
Kontakt:
Phone: 0041 61 265 25 25
E-Mail: elisabeth.kappos@usb.ch» Kontaktdaten anzeigen

Adriano Fabi, BMed
Kontakt:
Phone: 0041 79 888 12 51
E-Mail: adriano.fabi@uzh.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Elisabeth A Kappos, PD Dr. med.
Phone: 0041 61 265 25 25
E-Mail: elisabeth.kappos@usb.ch

Adriano Fabi, BMed
Phone: 0041 79 888 12 51
E-Mail: adriano.fabi@uzh.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. 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.

2. Date of follow-up procedure (Time Frame - baseline to follow up (no later than December 2024)):
Date of follow-up procedure.

3. 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

4. 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.

5. Postoperative complications (Time Frame - baseline to follow up (no later than December 2024)):
Postoperative complications

6. Surgery duration. (Time Frame - baseline to follow up (no later than December 2024)):
Surgery duration in minutes.

7. 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.

8. Date of lymphedema surgery (Time Frame - baseline to follow up (no later than December 2024)):
Date of lymphedema surgery.

9. Use of compression stockings (Time Frame - baseline to follow up (no later than December 2024)):
Use of compression stockings

10. Number of lymphedema drainages per week (Time Frame - baseline to follow up (no later than December 2024)):
Number of lymphedema drainages per week.

11. Stage of lymphedema (Time Frame - baseline to follow up (no later than December 2024)):
Stage of lymphedema (stage I, II or III)

12. Duration of lymphedema (Time Frame - baseline to follow up (no later than December 2024)):
Duration of lymphedema.

13. Location of lymphedema (Time Frame - baseline to follow up (no later than December 2024)):
Location of lymphedema.

14. Subsequent cancer treatment (Time Frame - baseline to follow up (no later than December 2024)):
Subsequent cancer treatment (Chemotherapy, Radiotherapy)

15. Date of cancer related surgery (Time Frame - baseline to follow up (no later than December 2024)):
Date of cancer related surgery

16. 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).

17. Tumor location (Time Frame - baseline to follow up (no later than December 2024)):
Tumor location (right, left, both sides).

18. BMI (Time Frame - baseline to follow up (no later than December 2024)):
Patient's BMI in kg/m2.

19. Comorbidities (Time Frame - baseline to follow up (no later than December 2024)):
Existence of comorbidities.

20. Age (Time Frame - baseline to follow up (no later than December 2024)):
Patient's age in years.

21. Gender (Time Frame - baseline to follow up (no later than December 2024)):
Patient's gender, given the possibilities male or female.

Secondary outcome:

1. 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 any kind of cancer prior to their lymphedema

2. 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 surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer

3. 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 who had no history of cancer and thus no cancer-related surgery in their medical history

4. 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 with chronic lymphedema regardless of whether or not they have an oncological history

5. 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: 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)

6. Analysis of cohort subgroups: exploratory (Time Frame - baseline to follow up (no later than December 2024)):
Analysis of cohort subgroups: exploratory

Quelle: ClinicalTrials.gov

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