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NCT02624388 · ClinicalTrials.gov registry record · Phase 2
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
A Phase 2 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02624388: Clinical Trial Phase 2 study, sponsored by University of Virginia.
NCT02624388 is a Phase 2 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02624388, a Phase 2 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.
Interventions
- DRUG Placebo
- DRUG Genistein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-08 |
| Est. Completion | 2021-09 |
| Phase | Phase 2 |
Why NCT02624388 stopped before completion
NCT02624388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02624388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02624388 about?
NCT02624388 is a clinical study titled "Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)". Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular da...
What is the current status of trial NCT02624388?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2016-08. Estimated completion is 2021-09.
What interventions are being tested in trial NCT02624388?
The interventions under investigation include: Placebo (DRUG), Genistein (DRUG).
Who is sponsoring clinical trial NCT02624388?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02624388's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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