Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/7/2018 |
| Start Date: | June 2006 |
| End Date: | June 2019 |
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.
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.
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.
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.
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)
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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