Axillary Reverse Mapping (ARM) Technique

Not Applicable

• Conditions: Invasive Breast Cancer; Ductal Carcinoma in Situ of the Breast
• Interventions: Procedure: axillary reverse mapping (ARM); Procedure: Standard axillary surgery (SLNB or ALND)

• Registration Number: NCT03109522
• Lead Sponsor: McMaster University

Brief Summary

The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.

Detailed Description

Lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (BC). Surgery for BC includes axillary surgery with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. The risk of lymphedema increases significantly with adjuvant radiation. Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either SLNB or ALND. This allows preservation of arm lymphatics unless there is suspicion of metastatic disease in ARM lymphatics or if the ARM node is/are also the sentinel lymph node. Studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing SLNB only. There is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.Our proposal is a prospective randomized pilot study. The study population includes patients undergoing axillary surgery (SLNB with mastectomy or ALND with either BCS or mastectomy or completion ALND after positive SLNB). The intervention group will undergo ARM; the control will undergo standard surgical treatment. Both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. The purpose is to determine the feasibility of the ARM technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-10-27
• Study Start: 2016-11
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment:

1. mastectomy and sentinel lymph node biopsy
2. breast conserving surgery or mastectomy and axillary lymph node dissection
3. completion axillary lymph node dissection after positive sentinel lymph node biopsy
4. cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment -

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Exclusion Criteria

1. males with breast cancer
2. women less than 18 years of age
3. known allergic reaction to patent blue dye
4. pregnant
5. previous radiation therapy to affected side
6. clinical N2/N3 disease -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
axillary reverse mapping	axillary reverse mapping (ARM)	Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND)
standard axillary surgery	Standard axillary surgery (SLNB or ALND)	The control group will have standard sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).

Primary Outcome Measures

Name	Time	Method
Lymphedema	Change from baseline to 12 months post-operative	Arm circumference measurements of both arms. An arm volume difference of \> 10% will be considered clinically significant lymphedema

Secondary Outcome Measures

Name	Time	Method
EORTC-QLQ-C30	Change from baseline to 12 months post-operative	General quality of life
Disabilities of the Arm and Shoulder and Hand (DASH)	Change from baseline to 12 months post-operative	arm symptoms and disabilities
Post-operative complications	30 days post-op	infection, hematoma, problems with wound healing
Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1	Change from baseline to 12 months post-operative	arm symptoms and pain

Trial Locations

Locations (2)

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital and Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada