Study to Assess Breast Sensation Before and After Breast Cancer Treatment

NCT02817607 | Withdrawn

• 1 other identifier: Pro00068908
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Ductal Carcinoma In-situ

Keywords

Sensation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Surgery

EXPERIMENTAL

Procedure: Sensory testing and Biopsy

Interventions

Sensory testing and Biopsy PROCEDURE

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.

Surgery

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Scott Hollenbeck, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)