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OpenTrials
Completed

NCT Number: NCT03376035

Pilot Study Assessing Breast Temperature in Breast Cancer Patients

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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Key information

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temperature measurement of breast

Other

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

Primary outcomes

  1. Change in skin temperature after breast reconstruction

    Time frame: 6 months after surgery

    Temperature measurements

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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