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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minoxidil | Experimental | All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast. |
|
| Hair mousse | Placebo Comparator | All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil | Drug | Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, as measured by recruitment rate | Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction | Day 1 |
| Feasibility, as measured by retention rate | Retention of enrolled participants until the clinical endpoint | 90 days |
| Feasibility, as measured by rate of participant adherence to the protocol | Rate of adherence to the treatment protocol | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Flap perfusion, assessed by a blinded plastic surgeon | 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. | Day of surgery |
| Flap perfusion, assessed by ICG angiography |
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Inclusion Criteria:
Exclusion Criteria:
High-risk for breast cancer diagnosis with desire to proceed with breast reconstruction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gallagher | Contact | 9199701551 | jennifer.gallagher@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brett Phillips, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Health | Recruiting | Durham | North Carolina | 27710 | United States |
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| Hair mousse | Drug | Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery. |
|
Perfusion is assessed using "relative value," which quantifies fluorescence as a percentage (%) relative to a reference point. |
| Day of surgery |
| Incidence of mastectomy skin flap necrosis | 90 days |
| Incidence of surgical complications | 90 days |
| Incidence of reoperations or definitive second-stage reconstruction | 90 days |
| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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