Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Axillary Reverse Mapping (ARM) in Breast Cancer Surgery to Prevent Lymphedema. (ARMtrial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03333226
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Carcoforo, University Hospital of Ferrara

Brief Summary:

Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm following axillary lymph nodes dissection, and it is associated to a significant functional, psychological and social morbidity, with an heavy impact on life quality. Several studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts. Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when compared with axillary lymph node dissection (ALND) leads to a significant reduction in postoperative complications. However, the advent of SLNB does not solve the problem of BCRL with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost of BCRL rehabilitative treatment is not available in literature yet. Few studies considered incidence, risk factors and treatment costs of BCRL among working-age women after breast cancer treatment, reporting that BCRL population had significantly higher rehabilitative medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications, such as lymphangitis or cellulitis when compared to "BCRL free" population (OR = 2.02, P = .009).

Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the primary breast cancer. However, when the arm lymph node correspond to the SLN it should be removed for correct tumor staging, thus a lymphatic drainage disruption onset will be expected with BCRL risk increase.

During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful for detecting lymphatic drainage of the upper limb and it allows in differentiating the fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).


Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Procedure: Axillary Reverse Mapping (ARM) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Eligible patients for radioguided sentinel lymph node biopsy (rSLNB) will be randomly divided in two groups:

  1. experimental group in which all patients will be sent to both rSLNB and photodynamic Axillary Reverse Mapping (ARM) to evaluate the crossover between SLN and ARM lymph node. In case of SLN metastases, an ALND with ARM lymph node preservation will be performed.
  2. control group in which all patients will be sent to both rSLNB and photodynamic Axillary Reverse Mapping (ARM) to evaluate the crossover between SLN and ARM lymph node. In case of SLN metastases, an ALND with ARM lymph node removal will be performed.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients will be randomized before the SLNB procedure. Due to the type of intervention, the blinding of the treating surgeon will not be possible, thus the surgeon will be aware of both the intraoperative crossover between ARM lymph node and SLN (secondary outcome) and the allocation to ARM lymph node preservation or removal. Data about BCRL (primary outcome) will be collected by the physiatrist and the physiotherapist that will be blinded about the allocation (ARM lymph node preservation/removal) and the crossover between SLN of the breast and the arm's lymph node. The assessment of lymphoscintigraphic subclinical modification in the arm lymphatic drainage after SLNB and ALND (secondary outcomes) will be performed by a blinded nuclear medicine physician that will not be aware of the allocation (ARM lymph node preservation/removal) and the crossover between ARM lymph node and breast's SLN.
Primary Purpose: Prevention
Official Title: Axillary Reverse Mapping (ARM). Identification of the Arm Lymphatic Pathways in Breast Cancer Surgery to Prevent Breast Cancer Related Lymphedema (BCRL): a Randomized Clinical Trial.
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM lymph node preservation
All patients will be sent to both rSLNB and photodynamic Axillary Reverse Mapping (ARM) to evaluate the crossover between SLN and ARM lymph node. In case of SLN metastases, an ALND with ARM lymph node preservation will be performed.
Procedure: Axillary Reverse Mapping (ARM)
ARM lymph node preservation versus removal

Active Comparator: ARM lymph node removal
All patients will be sent to both rSLNB and photodynamic Axillary Reverse Mapping (ARM) to evaluate the crossover between SLN and ARM lymph node. In case of SLN metastases, an ALND with ARM lymph node removal will be performed.
Procedure: Axillary Reverse Mapping (ARM)
ARM lymph node preservation versus removal




Primary Outcome Measures :
  1. Incidence of Breast Cancer Related Lymphedema (BCRL) after Axillary Lymph Node Dissection (ALND) [ Time Frame: From the day of surgery to 12 months after surgery ]
    Incidence of BCRL in patients in whom the ARM lymph node is preserved compared to those in which it is removed. Clinically follow-up will include the clinical presentation (pain, integumentary abnormalities, paresthesia, hypoesthesia, neuro-vascular deficits), standardized measurement of 7 records [diameters of the upper limb (hand, wrist, 15 cm and 10 cm distally to olecranon, elbow (olecranon), 10 cm and 15 cm proximally to olecranon)] and final conversion into volumes.


Secondary Outcome Measures :
  1. Incidence of Breast Cancer Related Lymphedema (BCRL) after Sentinel Lymph Node Biopsy (SLNB) alone [ Time Frame: From the day of surgery to 12 months after surgery ]
    Clinically follow-up will include the clinical presentation (pain, integumentary abnormalities, paresthesia, hypoesthesia, neuro-vascular deficits), standardized measurement of 7 records [diameters of the upper limb (hand, wrist, 15 cm and 10 cm distally to olecranon, elbow (olecranon), 10 cm and 15 cm proximally to olecranon)] and final conversion into volumes.

  2. Crossover between Sentinel Lymph Node (SLN) of the Breast and the ARM lymph node [ Time Frame: Intraoperatively ]
    Intraoperatively, the radioguided technique (Tc-99m Nanocoll) will be used to identify the SLN of the breast; at the same time, the Axillary Reverse Mapping (ARM) of the upper limb will be carried out by Indocyanine Green, and the ARM lymph node will be identified and preserved. If a crossover between SLN of the breast and the arm's lymph node will be find, the ARM lymph node identified by the photodynamic technique will be excised for pathological evaluation.

  3. Lymphoscintigraphic sub-clinical modifications of arm lymphatic drainage after ALND [ Time Frame: The day before ALND and at 60 days after ALND ]
    Bilateral arms lymphoscintigraphy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T1-T2 stage breast cancer

Exclusion Criteria:

  • axillary lymph node metastasis;
  • previous surgery on the ipsilateral axilla;
  • neoadjuvant chemo-radiotherapy;
  • presence of primitive lymphedema of the arm;
  • allergy to Iodine, thyroid disease, renal and hepatic impairment (for issues related to Indocyanine Green)
  • pregnancy;
  • patients refusing to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333226


Contacts
Layout table for location contacts
Contact: Paolo Carcoforo, MD 0039 0532 236123 paolo.carcoforo@unife.it
Contact: Mattia Portinari, MD 0039 0532 236100 mattia.portinari@unife.it

Locations
Layout table for location information
Italy
Azienda Ospedaliero Universitaria S. Anna Recruiting
Cona, Ferrara, Italy, 44124
Contact: Paolo Carcoforo, MD    0039 0532 236123    paolo.carcoforo@unife.it   
Contact: Mattia Portinari, MD    0039 0532 236100    mattia.portinari@unife.it   
Sponsors and Collaborators
University Hospital of Ferrara

Publications:

Layout table for additonal information
Responsible Party: Paolo Carcoforo, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03333226     History of Changes
Other Study ID Numbers: RF-2013-02358165
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Formal requests will be evaluated.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paolo Carcoforo, University Hospital of Ferrara:
Breast Neoplasms
Sentinel Lymph Node Biopsy
Lymph Node Excision
Technetium Tc 99m
Indocyanine Green
Lymphatic System
Secondary Prevention

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes