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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Withdrawn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

About this trial

This is an interventional basic science trial for Breast Reconstruction focused on measuring Sensation

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02817607

First Posted

June 27, 2016

Last Updated

May 3, 2019

Sponsor

Duke University

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Withdrawn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

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

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Study to Assess Breast Sensation Before and After Breast Cancer Treatment

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