NCT03376035

Pilot Study Assessing Breast Temperature in Breast Cancer Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Breast Reconstruction

Interventions

Type	Name	Description
OTHER	Temperature measurement of breast	Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

Timeline

• Start date: 2017-12-05
• Primary completion: 2019-01-07
• Completion: 2019-01-07
• First posted: 2017-12-18
• Last updated: 2019-01-08

Locations

1 site across 1 country: United States