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NCT01668849 · ClinicalTrials.gov registry record · Phase 1
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
A Phase 1 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01668849: Completed Phase 1 study, sponsored by University of Louisville.
NCT01668849 is a Phase 1 study that has completed, run by University of Louisville. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01668849, a Phase 1 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.
Primary Outcome
Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
Interventions
- DIETARY_SUPPLEMENT Grape extract
- DRUG Lortab, Fentanyl patch, mouthwash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-08-02 |
| Est. Completion | 2022-06-03 |
| Phase | Phase 1 |
What the finished NCT01668849 record still lists
NCT01668849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Grape extract is the first listed.
NCT01668849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01668849 about?
NCT01668849 is a clinical study titled "Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer". This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.
What is the current status of trial NCT01668849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-08-02. Estimated completion is 2022-06-03.
What interventions are being tested in trial NCT01668849?
The interventions under investigation include: Grape extract (DIETARY_SUPPLEMENT), Lortab, Fentanyl patch, mouthwash (DRUG).
Who is sponsoring clinical trial NCT01668849?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01668849's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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