Study to Assess Breast Sensation Before and After Breast Cancer Treatment

Breast Reconstruction Clinical Trial

Official title:

Pilot Study to Assess Breast Sensation Before and After Breast Cancer Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02817607
• Other study ID #: Pro00068908
• Status: Withdrawn
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: May 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma In-situ

Intervention

Procedure:
• Sensory testing and Biopsy
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in sensory perception score	change in sensory perception will be conducted using paired t-tests or Wilcoxon tests	baseline, time of surgery, 3 months, 6 months