Pilot Study Assessing Breast Temperature in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2019-01-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Reconstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Determine skin temperature after breast reconstruction

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unilateral breast reconstruction

Temperature measurements are obtained from the reconstructed breast and compared to the non-reconstructed breast.

Group Type ACTIVE_COMPARATOR

Temperature measurement of breast

Intervention Type OTHER

Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

Bilateral breast reconstruction

Temperature measurements are obtained from both reconstructed breasts and the core temperature is measured as well for comparison.

Group Type EXPERIMENTAL

Temperature measurement of breast

Intervention Type OTHER

Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

Interventions

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Temperature measurement of breast

Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No