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ACTIVE NOT RECRUITING
NCT03768492
PHASE2

Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

Interventions

DRUG

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

OTHER

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