Study to Assess Breast Sensation Before and After Breast Cancer Treatment
Primary Purpose
Breast Reconstruction, Ductal Carcinoma In-situ
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory testing and Biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Breast Reconstruction focused on measuring Sensation
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer
- patients that have been offered lumpectomy or mastectomy for surgical treatment
- patients with a high risk of breast cancer and are pursuing prophylactic mastectomies
Exclusion Criteria:
- metastatic malignancy of any kind
- subjects will not have breast surgery as a portion of their breast cancer care
- between 25 and 65 years old
- subjects with breast implants or a history of prior breast implants
- subjects that have had prior breast reduction surgery
- subjects who have had radiation to one of both breasts in the past
- subjects who cannot give informed consent
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery
Arm Description
Outcomes
Primary Outcome Measures
change in sensory perception score
change in sensory perception will be conducted using paired t-tests or Wilcoxon tests
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02817607
Brief Title
Study to Assess Breast Sensation Before and After Breast Cancer Treatment
Official Title
Pilot Study to Assess Breast Sensation Before and After Breast Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Study Start Date
December 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.
Detailed Description
Measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. A number of studies have assessed patients before and after breast reduction surgery using Semmes-Weinstein monofilaments and found this to be an effective technique. A limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. The main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. Additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Reconstruction, Ductal Carcinoma In-situ
Keywords
Sensation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sensory testing and Biopsy
Intervention Description
Semmes-Weinstein testing: Each breast will be subdivided into 5 regions. This will include the upper 1/3rd, the middle 1/3rd medial and lateral to the nipple areola complex, the lower 1/3rd and the nipple areola-complex. These regions are consistent with the dermatomes described for the breast innervation.
A cutaneous nerve/skin biopsy is a simple procedure commonly performed on an outpatient setting. The total procedure is expected to take 20 minutes and may be done at the time of surgery as well as 2 and 6 months post operatively either during a revision or at a follow up visit.
Primary Outcome Measure Information:
Title
change in sensory perception score
Description
change in sensory perception will be conducted using paired t-tests or Wilcoxon tests
Time Frame
baseline, time of surgery, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer
patients that have been offered lumpectomy or mastectomy for surgical treatment
patients with a high risk of breast cancer and are pursuing prophylactic mastectomies
Exclusion Criteria:
metastatic malignancy of any kind
subjects will not have breast surgery as a portion of their breast cancer care
between 25 and 65 years old
subjects with breast implants or a history of prior breast implants
subjects that have had prior breast reduction surgery
subjects who have had radiation to one of both breasts in the past
subjects who cannot give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Hollenbeck, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Breast Sensation Before and After Breast Cancer Treatment
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