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LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Primary Purpose

Lymphedema, Breast Cancer, Lymphedema

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

Axillary lymphadenetomy alone

About this trial

This is an interventional prevention trial for Lymphedema, Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Stanford Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Group A will under axillary lymphadenectomy alone

Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.

Outcomes

Primary Outcome Measures

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.

Limb Volume

Limb volume as measured by serial assessment

Skin thickness measurements

Skin thickness is changed by lymphedema

Bioiimpedance spectroscopy

Impedance of the skin changes with lymphedema

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05366699

First Posted

May 5, 2022

Last Updated

April 18, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT05366699

Brief Title

LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Suspended

Why Stopped

Regulatory

Study Start Date

September 10, 2021 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema, Breast Cancer, Lymphedema

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

After informed consent is obtained, all subjects will undergo an initial study evaluation to establish the pre-operative baseline and to determine eligibility for randomization. Group A will under axillary lymphadenectomy alone and Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System. Each of the baseline measures will be repeated at 3-month intervals over the 12 months of enrollment in the study. These include lymphography, limb volume measurements, skin thickness measurements, bioimpedance spectrosocpy, and quality-of-life assessment.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Group A will under axillary lymphadenectomy alone

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.

Intervention Type

Procedure

Intervention Name(s)

axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

Intervention Description

lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins

Intervention Type

Procedure

Intervention Name(s)

Axillary lymphadenetomy alone

Intervention Description

oncologic axillary lymphadenectomy

Primary Outcome Measure Information:

Title

Lymphatic flow pattern of whole limb

Description

Time Frame

2 yr

Title

Limb Volume

Description

Limb volume as measured by serial assessment

Time Frame

2 yr

Title

Skin thickness measurements

Description

Skin thickness is changed by lymphedema

Time Frame

2 yr

Title

Bioiimpedance spectroscopy

Description

Impedance of the skin changes with lymphedema

Time Frame

2 yr

Title

Quality of life

Description

Time Frame

2 yr

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Stanford Cancer Institute

City

San Francisco

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

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