Pilot Study Assessing Breast Temperature in Breast Cancer Patients



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:25 - 65
Updated:1/10/2019
Start Date:December 5, 2017
End Date:January 7, 2019

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Pilot Study Assessing Cutaneous Breast Temperature in the Setting of Mastectomy and Reconstruction

Our investigators plan to measure the skin on the breast six months after breast
reconstruction. The non-reconstructed breast will be used as the control for subject with
unilateral reconstruction only. For those who have BILATERAL reconstruction, a core
temperature will be obtained from the ear.

Many factors influence outcomes following mastectomy and breast reconstruction. Cutaneous
sensation, degree of scar formation, nipple projection and overall appearance are well
correlated with patient satisfaction. However, very little data exists on the importance of
skin temperature after mastectomy and reconstruction. Our investigators have noted that a
number of patients report their reconstructed breast is cold and relate this as a source of
dis-satisfaction. In these patients, it is unclear if 1) the reconstructed breast skin is
cold and if so 2) can something can be done to improve this. Our investigators hypothesize
that cutaneous breast temperature may be altered after mastectomy and reconstruction. This
may be dependent on the reconstruction technique and other patient factors. In this pilot
study, our investigators aim to establish techniques for evaluating cutaneous breast
temperature following mastectomy and reconstruction. Our investigators hope to establish
baseline data to develop an understanding of breast skin temperature after mastectomy and
reconstruction.

Our long-term goals are to evaluate how cutaneous breast temperature may contribute to
patient satisfaction. Our investigators also hope to determine which patients are at risk for
developing a cold breast after surgery. Finally, our investigators will setup a prospective
trial evaluating techniques to correct this problem and improve patient satisfaction.

Inclusion Criteria:

- For post-reconstruction patients: all patients who have undergone mastectomy and
breast reconstruction at Duke and are seen in clinic no sooner than 3 months after
reconstruction and no more than 5 years after reconstruction.

Exclusion Criteria:

- Metastatic malignancy of any kind.

- Subjects with a history of breast implant augmentation prior to mastectomy and
reconstruction.

- Subjects who cannot give an informed consent.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-970-1551
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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