Pilot Study Assessing Breast Temperature in Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction
• Intervention / Treatment: Other: Temperature measurement of breast

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unilateral breast reconstruction; Temperature measurements are obtained from the reconstructed breast and compared to the non-reconstructed breast.	Other: Temperature measurement of breast; Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.
Experimental: Bilateral breast reconstruction; Temperature measurements are obtained from both reconstructed breasts and the core temperature is measured as well for comparison.	Other: Temperature measurement of breast; Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin temperature after breast reconstruction	Temperature measurements	6 months after surgery

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): January 7, 2019
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00084743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No