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NCT02075112 · ClinicalTrials.gov registry record · Phase 1
Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02075112: Completed Phase 1 study, sponsored by Emory University.
NCT02075112 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02075112, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.
Primary Outcome
The primary outcome of this study is the percentage of patients with symptomatic (grade 2 or higher) xerostomia at 1 year post-treatment, assessed by the Late Effects of Normal Tissues (LENT)/Subjective, Objective, Management, Analytic (SOMA) method.
Interventions
- DRUG Cisplatin
- RADIATION Radiation
- DRUG Soy isoflavone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-11 |
| Est. Completion | 2019-09 |
| Phase | Phase 1 |
What the finished NCT02075112 record still lists
NCT02075112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT02075112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02075112 about?
NCT02075112 is a clinical study titled "Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck". The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce thi...
What is the current status of trial NCT02075112?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-11. Estimated completion is 2019-09.
What interventions are being tested in trial NCT02075112?
The interventions under investigation include: Cisplatin (DRUG), Radiation (RADIATION), Soy isoflavone (DRUG).
Who is sponsoring clinical trial NCT02075112?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02075112's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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