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NCT02411565 · ClinicalTrials.gov registry record · Early Phase 1
Fermented Wheat Germ Extract in Women With Ovarian Cancer
A Early Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT02411565: Clinical Trial Early Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02411565 is a Early Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02411565, a Early Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The main purpose of this Pilot Study is to test the safety, tolerability and quality of life in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of FWGE can be detected in the blood, and determine whether short-term therapy with FWGE has any effect on the tumor marker, cancer antigen 125 (CA-125).
Primary Outcome
Adverse events reported per treatment arm. An adverse event is the development of an untoward medical occurrence, undesirable medical condition, or recurrence or deterioration of a pre-existing medical condition subsequent to exposure to FWGE. This study will utilize the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for toxicity and adverse event reporting. Number of Adverse Events Probably Related to Study Treatment. All Adverse Events are listed, with causality noted
Interventions
- DRUG Placebo
- DRUG Fermented Wheat Germ Extract (FWGE)
- OTHER Standard of Care: Planned Surgery
- OTHER Quality of Life (QoL) Surveys: FACT-O
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2018-01-08 |
| Phase | Early Phase 1 |
Why NCT02411565 stopped before completion
NCT02411565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02411565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02411565 about?
NCT02411565 is a clinical study titled "Fermented Wheat Germ Extract in Women With Ovarian Cancer". The main purpose of this Pilot Study is to test the safety, tolerability and quality of life in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of FWGE can be detected in the blood, and determine whether short-term therapy with FWGE has any effect on the tumor mark...
What is the current status of trial NCT02411565?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2016-03-01. Estimated completion is 2018-01-08.
What interventions are being tested in trial NCT02411565?
The interventions under investigation include: Placebo (DRUG), Fermented Wheat Germ Extract (FWGE) (DRUG), Standard of Care: Planned Surgery (OTHER), Quality of Life (QoL) Surveys: FACT-O (OTHER).
Who is sponsoring clinical trial NCT02411565?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02411565's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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