Study to Assess Breast Sensation Before and After Breast Cancer Treatment

Not Applicable

Withdrawn

• Conditions: Breast Reconstruction; Ductal Carcinoma In-situ
• Interventions: Procedure: Sensory testing and Biopsy

• Registration Number: NCT02817607
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Study Start: 2016-12
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Sensory testing and Biopsy	-

Primary Outcome Measures

Name	Time	Method
change in sensory perception score	baseline, time of surgery, 3 months, 6 months	change in sensory perception will be conducted using paired t-tests or Wilcoxon tests

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States