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Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Sponsor: NYU Langone Health
Summary
The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.
Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2020-06-29
Completion Date
2027-12
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
Caffeine anhydrous 5% added to Lipoderm Cream Base.
Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
Lipoderm Cream Base
Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
Locations (1)
New York University Medical Center
New York, New York, United States