Minoxidil for Breast Reconstruction

Overseen By Jennifer Gallagher

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Duke University

Disqualifiers: Breast cancer, History of cancer, Pregnancy, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a topical solution called minoxidil can improve blood flow and skin flap health during breast reconstruction surgery. Participants will apply two different solutions to their breasts before surgery: one containing minoxidil and the other a placebo (a non-active treatment). Women with a genetic risk for cancer who plan to undergo a preventive double mastectomy and reconstruction are ideal candidates for this study. The goal is to determine if minoxidil can enhance healing in the surgical area by improving circulation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical research.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that low doses of minoxidil are generally safe for women, including those undergoing breast cancer treatment. One study found that minoxidil did not cause serious heart-related issues in these patients. This finding suggests that the topical form of minoxidil, similar to the one used in the breast reconstruction trial, might also be well-tolerated. Minoxidil is already used to promote hair growth, supporting its safety profile. Although the current study remains in the early stages, this background provides some confidence in its safety for trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard methods for breast reconstruction, which typically involve surgery and implants, topical Minoxidil offers a non-invasive alternative. Researchers are excited about this treatment because it uses Minoxidil, a well-known hair growth stimulant, in a novel way. By applying it directly to the skin, it may promote faster and potentially enhanced healing and tissue regeneration. This unique approach could make recovery easier and more effective for patients undergoing breast reconstruction.

What evidence suggests that minoxidil might be an effective treatment for improving flap perfusion and viability in breast reconstruction?

Research has shown that topical minoxidil might improve blood flow and tissue health, which is crucial for successful surgery. A study on similar treatments found that minoxidil increased blood flow in certain situations. While primarily known for promoting hair growth, it might also aid in tissue healing, making it promising for breast reconstruction. In this trial, all participants will receive both the study drug, topical minoxidil, and a placebo solution, applied to different breasts. Minoxidil's ability to reduce cell movement suggests it could enhance surgical outcomes. Although more research is needed, these findings indicate it could improve the success of breast reconstruction surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Brett Phillips, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for patients planning to undergo bilateral risk-reducing mastectomy with reconstruction due to genetic susceptibility or high risk of developing breast cancer. Participants will have one breast treated with minoxidil and the other as a control.

Inclusion Criteria

I have a genetic risk for cancer.

I am having both breasts removed and reconstructed on the same day to prevent cancer.

I understand the study and can agree to participate.

Exclusion Criteria

Currently pregnant or planning to be pregnant (for women of child-bearing potential)

I have had cancer in the past.

I have been diagnosed with breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants apply the study drug and placebo to each breast for 2 weeks prior to surgery

2 weeks

1 visit (in-person) for pre-operative instructions

Surgery

Participants undergo bilateral risk-reducing mastectomy with reconstruction

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of flap perfusion

90 days

Multiple visits (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Topical Minoxidil

Trial Overview The study tests if applying minoxidil, commonly used for hair growth, can improve blood flow and tissue health in flaps created during reconstructive breast surgery. One breast gets minoxidil; the other gets a placebo, decided randomly.

How Is the Trial Designed?

Group I: Minoxidil Experimental Treatment 1 Intervention

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.

Group II: Hair mousse Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07264790

Assessment of Topical Minoxidil on Intraoperative Flap ... The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy ...

2. nyulangone.org nyulangone.org/news/hair-growth-drug-safe-low-doses-breast-cancer-patients

Hair Growth Drug Safe at Low Doses for Breast Cancer ... A study in women with breast cancer suggests that low oral doses of minoxidil, taken during or after cancer treatment, appear to regrow hair in most patients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9338910/

Anti-invasive effects of minoxidil on human breast cancer cells (2) Matrigel invasion was significantly reduced in a dose-dependent manner by MIN under both normoxia and hypoxia; RAN was effective only under hypoxia. The ...

4. journals.lww.com journals.lww.com/prsgo/fulltext/2024/01001/exploring_the_effects_of_topical_minoxidil,.5.aspx

Exploring the Effects of Topical Minoxidil, Tacrolimus, and .. ... Results: The average full perfusion (viable) areas for topical minoxidil, tacrolimus, and control were 41.4%, 50.9%, and 41.4%, respectively. Tacrolimus led to ...

5. jaad.org jaad.org/article/S0190-9622(22)03261-3/abstract

Efficacy of low-dose oral minoxidil in the management ... Using quantitative measurements, we assessed the efficacy of LDOM in patients with breast cancer diagnosed with pCIA and/or EIA.

6. curetoday.com curetoday.com/view/minoxidil-may-safely-aid-in-hair-growth-for-patients-with-breast-cancer

Minoxidil May Safely Aid in Hair Growth for Patients With ... Low-dose oral minoxidil, the hair growth drug that is the active ingredient in Rogaine, may be safe and effective for patients with breast cancer.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S019096222500605X

Summation and recommendations for the safe ... Clinical review. Summation and recommendations for the safe and effective use of topical and oral minoxidil.