Invasive Breast Cancer Clinical Trial
— ARMOfficial title:
A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
Verified date | February 2020 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 130 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 - |
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Hospital and Cancer Centre | Hamilton | Ontario |
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lymphedema | Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema | Change from baseline to 6 months post-operative | |
Primary | Lymphedema | Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema | Change from baseline to 12 months post-operative | |
Secondary | EORTC-QLQ-C30 | General quality of life | Change from baseline to 6 months post-operative | |
Secondary | EORTC-QLQ-C30 | General quality of life | Change from baseline to 12 months post-operative | |
Secondary | Disabilities of the Arm and Shoulder and Hand (DASH) | arm symptoms and disabilities | Change from baseline to 6 months post-operative | |
Secondary | Disabilities of the Arm and Shoulder and Hand (DASH) | arm symptoms and disabilities | Change from baseline to 12 months post-operative | |
Secondary | Post-operative complications | infection, hematoma, problems with wound healing | 30 days post-op | |
Secondary | Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 | arm symptoms and pain | Change from baseline to 6 months post-operative | |
Secondary | Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 | arm symptoms and pain | Change from baseline to 12 months post-operative |
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