Pilot Study Assessing Breast Temperature in Breast Cancer Patients

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376035
• Other study ID #: Pro00084743
• Status: Completed
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: January 7, 2019

Study information

• Verified date: January 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Other:
• Temperature measurement of breast
Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skin temperature after breast reconstruction	Temperature measurements	6 months after surgery