Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition
Conditions
Brief summary
The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at the time of surgery. Patients will undergo randomization of their breasts to determine which breast will receive the experimental intervention and which breast will serve as the internal control (receive placebo). The experimental breast will receive the novel pharmacologic delay treatment, 5% minoxidil, while the internal control breast will receive the current standard of care, which does not include any topical application prior to surgery - a placebo control will be used. This will be a triple-blind study, where both the participants and investigators will be blinded to which breast will receive the intervention. The patients will receive two bottles compound A and compound B with directions from the pharmacy for which compound to apply to each breast. Product will be applied for 2 weeks prior to planned surgery. Surgery will proceed without any changes to standard practice.
Interventions
DRUGMinoxidil
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
DRUGHair mousse
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female sex \> 18 years old 2. Genetic predisposition to cancer 3. Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction 4. Capable of giving informed consent
Exclusion criteria
1. Diagnosis of breast cancer 2. History of cancer 3. Currently pregnant or planning to be pregnant (for women of child-bearing potential) 4. Male sex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, as measured by recruitment rate | Day 1 | Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction |
| Feasibility, as measured by retention rate | 90 days | Retention of enrolled participants until the clinical endpoint |
| Feasibility, as measured by rate of participant adherence to the protocol | 90 days | Rate of adherence to the treatment protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical complications | 90 days | — |
| Flap perfusion, assessed by a blinded plastic surgeon | Day of surgery | A third-party blinded plastic surgeon will visually evaluate flap perfusion, from preoperative and intraoperative photos, and SPY-QP video and use their clinical judgement to assess perfusion. |
| Incidence of reoperations or definitive second-stage reconstruction | 90 days | — |
| Flap perfusion, assessed by ICG angiography | Day of surgery | Perfusion is assessed using relative value, which quantifies fluorescence as a percentage (%) relative to a reference point. |
| Incidence of mastectomy skin flap necrosis | 90 days | — |
Countries
United States
Contacts
Primary ContactJennifer Gallagher
Outcome results
None listed