Lymphovenous Anastomosis for Breast Cancer Lymphedema

Lymphedema Clinical Trial

Official title:

Lymphovenous Anastomosis for Breast Cancer-related Lymphedema: A Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302361
• Other study ID #: 23/54225
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Odense University Hospital
• Contact: Caroline Lilja, MD
• Phone: +4560555340
• Email: caroline.lilja[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.

Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.

Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.

The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.

The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

Description:

This comprehensive single-armed cohort study is dedicated to assessing the effectiveness of lymphovenous anastomosis (LVA) in treating pitting lymphedema among adult female patients who have undergone breast cancer treatment.

This study builds upon findings from our preliminary pilot study at Odense University Hospital, and is conducted across several hospitalt in Denmark, including Odense University Hospital, Lillebælt Hospital Vejle, Zealand University Hospital Roskilde, and Herlev Hospital.

The study's primary aim is to determine whether LVA can significantly reduce arm volume and improve the overall quality of life for patients afflicted with breast cancer-related lymphedema.

Inclusion Criteria and Patient Recruitment The study population consists of women over 18 years of age suffering from unilateral arm lymphedema secondary to breast cancer treatment. Key eligibility criteria include active pitting lymphedema, presence of dermal backflow as evidenced by indocyanine green lymphography, identifiable lymphatic vessels in the affected arm, and the ability to provide informed consent and complete questionnaires in Danish.

Prospective participants are identified during clinical assessments at the participating hospitals' Departments of Plastic Surgery. Those deemed suitable for LVA surgery by consulting surgeons are invited to participate, ensuring informed consent through both oral and written communication.

Method This multi-center cohort study employs a range of outcome measures to evaluate the impact of LVA surgery. Primary outcomes focus on changes in arm volume, measured through water displacement volumetry and arm circumferential measurements, employing the unaffected arm as a control.

Secondary outcomes include assessments of body composition via bioimpedance spectroscopy, health-related quality of life through the LYMPH-Q questionnaire, arm function via the DASH questionnaire, general quality of life via the SF-36 questionnaire, patency of anastomosis validated by ICG lymphography, changes in ICG lymphography images, and arm fibrosis measured with the SkinFibroMeter.

Data collected are entered into a secure database for analysis. This includes comparing pre- and postoperative measurements to assess the primary and secondary outcomes.

Surgical Procedure and Follow-up LVA surgeries are performed by surgeons at Odense University Hospital and Herlev Hospital, with the choice between local or general anesthesia based on the number of planned anastomoses and patient preference.

Patients will be seen prior to surgery for baseline measurements, in addition to six and twelve months post-operative follow-up. At three and nine months post-operative, phone consultations will be performed for reminders of questionnaires and patient safety.

The study prohibits participants from undergoing other medical or surgical treatments for lymphedema during the trial period, although conservative treatments like compression garments are accepted.

Data Management and Ethics Adhering to the ethical standards, this study complies with Good Clinical Practice, The Danish Code of Conduct for Research Integrity, and GDPR. It has sought approval from the Research Ethics Committee of the Region of Southern Denmark. Patient safety is paramount, with LVA considered a safe and valid treatment option.

Feasibility and Publication Led by Caroline Lilja, MD, and Ph.D. student, under the supervision of Jørn Bo Thomsen, Dr., MD., Ass. Prof., the study aims for results publication regardless of the outcome, emphasizing its contribution to the field and potential impact on treatment protocols for lymphedema patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18

• Female

• Unilateral arm lymphedema secondary to breast-cancer treatment

• Active pitting lymphedema

• Presence of dermal backflow in indocyanine green lymphography

• Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green

• Able to provide informed consent

• Able to read, understand and complete Danish questionnaires

Exclusion Criteria:

• Allergy to iodine

• Pregnant, breast-feeding, or aiming to conceive withing the next year

• History of bilateral breast cancer

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema Arm
• Lymphedema of Upper Limb
• Lymphedema, Breast Cancer
• Lymphedema, Secondary
• Lymphedema; Surgical

Intervention

Procedure:
• Lymphovenous anastomosis (LVA)
Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.

Locations

Country	Name	City	State
Denmark	Department of Plastic Surgery, Odense University Hospital	Odense	Region Of Southern Denmark

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Herlev and Gentofte Hospital, Vejle Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm volume (Water Displacement)	Changes of arm volume difference	Baseline, six months, twelve months
Primary	Arm volume (Arm Circumferences)	Changes of arm volume difference	Baseline, six months, twelve months
Secondary	Health-related quality of life (LYMPH-Q)	Changes of health-related quality of life, measured with LYMPH-Q	baseline, three months, six months, nine months, twelve months
Secondary	General quality of life (SF-36)	Changes of health-related quality of life measured with SF-36	baseline, three months, six months, nine months, twelve months
Secondary	Arm and shoulder function (DASH)	Changes in arm and shoulder function, measured with DASH	baseline, three months, six months, nine months, twelve months
Secondary	L-Dex	Changes in L-Dex score	Baseline, six months, twelve months
Secondary	LVA patency	Evaluation of patency using indocyanine green lymphography postoperatively. Number of patent anastomosis will be compared to number performed during surgery.	Baseline, six months
Secondary	Skin Fibrosis	The degree of skin fibrosis measured with SkinFibroMeter	Baseline, six months, twelve months
Secondary	Surgery duration	The duration of surgery will be compared between sites	Day of intervention
Secondary	Body composition	Changes in body compositions measured with SoZo bioimpedance will be evaluated.	Baseline, six months, twelve months