Trials / Active Not Recruiting
Active Not RecruitingNCT03768492
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-06-29
- Primary completion
- 2025-12-01
- Completion
- 2027-12-01
- First posted
- 2018-12-07
- Last updated
- 2025-07-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03768492. Inclusion in this directory is not an endorsement.