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Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

21 Years
Open (Enrolling)
Breast Cancer, Cancer

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Trial Information

Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

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

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.

Inclusion Criteria:

- Patients who have undergone mastectomy

- Patients who have undergone immediate, twostage expander/implant breast

- 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)

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Babak Mehrara, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Cancer
  • Breast Cancer
  • Cancer
  • Breast Sensation
  • Postmastectomy Breast Reconstruction
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021