Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

NCT00588419 | Completed

• 1 other identifier: 06-047
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the return of sensation in the breast(s) following breast mastectomy with and without reconstruction. Four different sensations: touch, vibration, superficial pain, and temperature will be evaluated. In addition, we will look at factors that may contribute to the return of breast sensations.

Conditions

Breast Cancer; Cancer

Keywords

Breast Cancer; Cancer; Breast Sensation; Postmastectomy Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Evaluate the degree of touch, vibration, superficial pain, and temperature sensation recovered in the postmastectomy as well as in the reconstructed breast and to compare the sensations recovered in the different groups.

  1 year

Secondary Outcomes (1)

• The secondary objective is to compare the sensations recovered following tissue expander/implant breast reconstruction with sensations recovered following autogenous tissue reconstruction.

  1 year

Study Arms (1)

1

Patients who have undergone mastectomy Patients who have undergone immediate, twostage expander/implant breast reconstruction; Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction

Behavioral: breast exam and questionaire

Interventions

breast exam and questionaire BEHAVIORAL

A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.

1

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited by their attending surgeon when they return to their surgeon's office for a postoperative appointment following their qualifying surgery

You may qualify if:

• Patients who have undergone mastectomy
• Patients who have undergone immediate, twostage expander/implant breast reconstruction
• Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction
• Patients at least 21 years of age
• Patients at least 1 year from the time of mastectomy or completion of immediate, postmastectomy reconstruction

You may not qualify if:

• Patients who have had any of the following:
• delayed reconstruction (no reconstruction immediately after mastectomy)
• combined autogenous tissue/implant breast reconstruction
• tissue expander
• Patients who have a history of complex regional pain syndrome
• implant explantation (device is removed prematurely due to complications)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Babak Mehrara, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2007
• First Posted: January 8, 2008
• Study Start: June 1, 2006
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

US (1)