A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema, Breast Cancer
- Sponsor
- Stanford University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Skin thickness measurements
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Skin thickness measurements
Time Frame: 2 yr
Skin thickness is changed by lymphedema
Limb Volume
Time Frame: 2 yr
Limb volume as measured by serial assessment
Lymphatic flow pattern of whole limb
Time Frame: 2 yr
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.
Bioiimpedance spectroscopy
Time Frame: 2 yr
Impedance of the skin changes with lymphedema
Quality of life
Time Frame: 2 yr
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