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NCT03768492 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
A Phase 2 study of Carcinoma, Breast, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03768492: Active Phase 2 study of Carcinoma, Breast, sponsored by NYU Langone Health.
NCT03768492 is a Phase 2 study of Carcinoma, Breast that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03768492, a Phase 2 study of Carcinoma, Breast, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Caffeine anhydrous 5% added to Lipoderm Cream Base.
- OTHER Lipoderm Cream Base
Study Locations (1)
New York
- New York University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT03768492 still lists
NCT03768492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Carcinoma, Breast appearing as the primary indexed condition, and to 2 interventions - of which Caffeine anhydrous 5% added to Lipoderm Cream Base. is the first listed.
NCT03768492 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03768492 about?
NCT03768492 is a clinical study titled "Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy". 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.
What is the current status of trial NCT03768492?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-06-29. Estimated completion is 2027-12.
What conditions does trial NCT03768492 study?
This clinical trial studies the following conditions: Carcinoma, Breast.
What interventions are being tested in trial NCT03768492?
The interventions under investigation include: Caffeine anhydrous 5% added to Lipoderm Cream Base. (DRUG), Lipoderm Cream Base (OTHER).
Who is sponsoring clinical trial NCT03768492?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03768492 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Breast
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03768492's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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