LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Lymphedema Clinical Trial

Official title:

A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05366699
• Other study ID #: IRB-53132
• Secondary ID: NCI-2022-05172BR
• Status: Suspended
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: June 1, 2030

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ages 18 to 75 years (inclusive)

• Patients undergoing unilateral or bilateral breast cancer related axillary lymphadenectomy

• Free of distant metastasis in preoperative screening

• Histology results of axillary lymph nodes could be either Negative or Positive

• Patients who undergo preoperative chemotherapy can be included

• Willingness and ability to provide written informed consent

• Willingness and ability to comply with all study procedures

Exclusion Criteria:

• Primary lymphedema of the affected upper limb

• Secondary lymphedema of the affected limb prior to the lymphadenectomy

• Radiotherapy at the axilla before the study / surgery

• Allergic reaction to porcine collagen or ICG

• Receiving radiation therapy to the involved nodal basin in a period less than 4 weeks after the surgery

• Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening

• Other medical condition that could lead to limb edema, such as (but not limited to primary lymphedema or acute venous thrombosis

• Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)

• Either of the following, at the time of baseline evaluation: ipsilateral:contralateral limb volume ratio>1.1 or R0 bioimpedance ratio > 1.106 when the nondominant limb is at risk, and 1.134 when the dominant limb is at risk.

• Life expectancy < 2 years for any reason

• Pregnancy or nursing

• Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening

• Severe psychiatric disease

• Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support

• Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening

• Absolute neutrophil count < 1500 mm3 at screening

• Hemoglobin concentration < 9 g/dL at screening

• Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema
• Lymphedema, Breast Cancer

Intervention

Procedure:
• axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
• Axillary lymphadenetomy alone
oncologic axillary lymphadenectomy

Locations

Country	Name	City	State
United States	Stanford Cancer Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphatic flow pattern of whole limb	In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy.	2 yr
Primary	Limb Volume	Limb volume as measured by serial assessment	2 yr
Primary	Skin thickness measurements	Skin thickness is changed by lymphedema	2 yr
Primary	Bioiimpedance spectroscopy	Impedance of the skin changes with lymphedema	2 yr
Primary	Quality of life	Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score	2 yr