Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588419
• Other study ID #: 06-047
• Status: Completed
• Start date: June 2006
• Est. completion date: April 7, 2021

Study information

• Verified date: April 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study entitled "The Quantification of Breast Sensations Following Postmastectomy Breast Reconstruction" will evaluate the recovery of sensation in the reconstructed as well as in the nonreconstructed breast. Touch, vibration, pain and temperature sensation will be objectively evaluated greater than 1 year following completion of reconstruction. Breast sensation following immediate, tissue expander/implant breast reconstruction will be compared with that following immediate, autogenous tissue reconstruction. A formal sensory examination will be performed. SemmesWeinstein monofilaments will evaluate touchpressure sensation in the breast. A Bioesthesiometer will determine the recovery of vibratory sensation. Temperature sensation will be evaluated by application of warm and cool stimuli. Superficial pain sensation will be evaluated by application of sharp and dull stimuli. A patient reported assessment of sensory changes in the breast will be administered to patients. The Breast Sensation Assessment Scale © is designed to measure the prevalence, severity, and distress of 18 different sensory symptoms following breast surgery. A "Patient Demographic and Treatment Information Form" and patients' medical records will be used to obtain demographic and treatment data. The role of confounding variables (including: patient age, breast volume, axillary procedures performed and adjuvant therapies received) on the recovery of sensation will be evaluated. The estimated accrual time for this study is 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria:

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

Intervention

Behavioral:
• breast exam and questionaire
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary objective is to compare the sensations recovered following tissue expander/implant breast reconstruction with sensations recovered following autogenous tissue reconstruction.		1 year

External Links

•   Memorial Sloan-Kettering web site