Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588419
First received: December 24, 2007
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Cancer
Behavioral: breast exam and questionaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to compare the sensations recovered following tissue expander/implant breast reconstruction with sensations recovered following autogenous tissue reconstruction. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: June 2006
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588419

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Babak Mehrara, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588419     History of Changes
Other Study ID Numbers: 06-047
Study First Received: December 24, 2007
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast Cancer
Cancer
Breast Sensation
Postmastectomy Breast Reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014