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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
New York University Medical Center
New York, New York, United States
Standard Toxicity Scoring
The US National Cancer Institute developed the Common Terminology Criteria for Adverse Events (CTCAE), which was formerly called the Common Toxicity Criteria (CTC), which is a standardized classification of adverse effects in cancer therapy. The current version 5.0 was released in 2017. The criteria uses a grading system of 1 to 5 (e.g. Grade 1 = mild and Grade 5 = death related to AE).
Time frame: 4 Years
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