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NCT07668284 · ClinicalTrials.gov registry record · Phase 1
COQ10 and Vitamin E for Off-Target Radiation Toxicity
A Phase 1 study, sponsored by University of Nebraska.
- Not yet
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
NCT07668284: Clinical Trial Phase 1 study, sponsored by University of Nebraska.
NCT07668284 is a Phase 1 study that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 200 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (233% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07668284, a Phase 1 study, has not yet begun recruiting, sponsored by University of Nebraska.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
Study Summary
The goal of this supportive care study is to learn if high-dose Vitamin E and CoQ10 in combination can reduce the negative sub-acute and chronic side effects of radiation to the pelvis in adults treated for prostate, uterine, cervical, or anal cancer. The main questions it aims to answer are: * Is taking high doses of Vitamin E (dl-α-tocopherol acetate, 900mg) and CoQ10 (ubidecarenone, 200 mg) each day safe and tolerable? * Does a 90-day course of vitamin supplementation with high-dose Vitamin E and CoQ10 reduce the incidence and severity of late radiation-associated toxicities? * Does high-dose vitamin supplementation with Vitamin E and CoQ10 improve patient reported measure of quality of life? * Does high-dose vitamin supplementation with Vitamin E and CoQ10 change the trajectory of recovery after radiation therapy? * Is there evidence that suggests high-dose vitamin supplementation with Vitamin E and CoQ10 impairs oncologic outcomes? * Can longitudinal biomarkers of oxidative stress be correlated with Vitamin E and CoQ10 concentrations or radiation-associated toxicity? * Will subjects adhere to the vitamin administration schedule? * Are there demographic differences in systemic exposure to the vitamins? * Are there differences in toxicity outcomes across tumor types or radiation dose fractionation schemes? Participants will be asked to: * Take Vitamin E and CoQ10 every day for 90 days by mouth. * Fill out quality of life questionnaires to assess treatment impacts. * Come for clinic visits every 2-4 weeks for around 4 months, then every 3-6 months for around 2 years. * Have blood draws more frequently than standard-of-care for clinical laboratory examinations and the collection of research samples. * Undergo Computed Tomography (CT) imaging of the chest, abdomen, and pelvis more frequently than standard of care. * Agree to lifestyle changes that ensure adequate vitamin absorption including intermittent abstinence from alcoholic beverages.
Primary Outcome
Determine if the initial dose of each vitamin is recommended for the remainder of study participants.
Interventions
- DRUG Coenzyme Q10 Cap/Tab
- DRUG Vitamin E Cap/Tab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-12-15 |
| Phase | Phase 1 |
What is known before NCT07668284 opens enrollment
NCT07668284 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (233% higher).
The record links to 0 conditions, and to 2 interventions - of which Coenzyme Q10 Cap/Tab is the first listed.
NCT07668284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07668284 about?
NCT07668284 is a clinical study titled "COQ10 and Vitamin E for Off-Target Radiation Toxicity". The goal of this supportive care study is to learn if high-dose Vitamin E and CoQ10 in combination can reduce the negative sub-acute and chronic side effects of radiation to the pelvis in adults treated for prostate, uterine, cervical, or anal cancer. The main questions it aims to answer are: * Is...
What is the current status of trial NCT07668284?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2026-07-01. Estimated completion is 2030-12-15.
What interventions are being tested in trial NCT07668284?
The interventions under investigation include: Coenzyme Q10 Cap/Tab (DRUG), Vitamin E Cap/Tab (DRUG).
Who is sponsoring clinical trial NCT07668284?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07668284's enrollment target sits among peer trials
200 259th of 2000 higher than 1,724 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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