Clinical trial NCT03109522: Axillary Reverse Mapping (ARM) Technique
Official title: A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Invasive Breast Cancer
Ductal Carcinoma in Situ of the Breast
Keywords: axillary reverse mapping (ARM)
sentinel lymph node biopsy (SLNB)
axillary lymph node dissection (ALND)
lymphedema
breast cancer
surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: St. Joseph's Healthcare Hamilton
First posted: 2017-04-12
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

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 -

Primary outcomes:
measure: Lymphedema
timeFrame: Change from baseline to 6 months post-operative
measure: Lymphedema
timeFrame: Change from baseline to 12 months post-operative
Secondary outcomes:
measure: EORTC-QLQ-C30
timeFrame: Change from baseline to 6 months post-operative
measure: EORTC-QLQ-C30
timeFrame: Change from baseline to 12 months post-operative
measure: Disabilities of the Arm and Shoulder and Hand (DASH)
timeFrame: Change from baseline to 6 months post-operative
measure: Disabilities of the Arm and Shoulder and Hand (DASH)
timeFrame: Change from baseline to 12 months post-operative
measure: Post-operative complications
timeFrame: 30 days post-op
measure: Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
timeFrame: Change from baseline to 6 months post-operative
measure: Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1
timeFrame: Change from baseline to 12 months post-operative
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Peter Lovrics, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Nicole Hodgson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: