Study to Assess Breast Sensation Before and After Breast Cancer Treatment
Status
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Details and patient eligibility
About
The purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.
Full description
Measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. A number of studies have assessed patients before and after breast reduction surgery using Semmes-Weinstein monofilaments and found this to be an effective technique. A limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. The main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. Additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.
Sex
Ages
Volunteers
Inclusion criteria
- patients diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer
- patients that have been offered lumpectomy or mastectomy for surgical treatment
- patients with a high risk of breast cancer and are pursuing prophylactic mastectomies
Exclusion criteria
- metastatic malignancy of any kind
- subjects will not have breast surgery as a portion of their breast cancer care
- between 25 and 65 years old
- subjects with breast implants or a history of prior breast implants
- subjects that have had prior breast reduction surgery
- subjects who have had radiation to one of both breasts in the past
- subjects who cannot give informed consent
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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