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NCT01878695 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer
A Phase 1 study of Stage 0/1 Breast Cancer and Post Biopsy, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01878695: Completed Phase 1 study of Stage 0/1 Breast Cancer and Post Biopsy, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01878695 is a Phase 1 study of Stage 0/1 Breast Cancer and Post Biopsy that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01878695, a Phase 1 study of Stage 0/1 Breast Cancer and Post Biopsy, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. In the exercise physiology literature, both oral and injectable NAC have been shown to reduce fatigue and improve recovery from exertion which has interesting implications for exploring cancer-related fatigue. In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in the development and progression of breast cancer
Primary Outcome
To assess the feasibility of evaluating the effect of n-acetylcysteine on tumor cell metabolism by assessing the changes in expression of caveolin -1 and MCT4 in cancer associated fibroblasts in pre and post therapy breast tissue treated with NAC.
Conditions Studied
Interventions
- DRUG IV/oral n-acetylcysteine
Study Locations (1)
Pennsylvania
- Jefferson Myrna Brind Center for Integrative Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-07-26 |
| Est. Completion | 2015-05-14 |
| Phase | Phase 1 |
What the finished NCT01878695 record still lists
NCT01878695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Stage 0/1 Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which IV/oral n-acetylcysteine is the first listed.
NCT01878695 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01878695 about?
NCT01878695 is a clinical study titled "Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer". NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. In the exercise physiology literature, both oral and injectab...
What is the current status of trial NCT01878695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-07-26. Estimated completion is 2015-05-14.
What conditions does trial NCT01878695 study?
This clinical trial studies the following conditions: Stage 0/1 Breast Cancer, Post Biopsy, Pre-surgery.
What interventions are being tested in trial NCT01878695?
The interventions under investigation include: IV/oral n-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT01878695?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01878695 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01878695's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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