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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 is a Phase 1 study that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 200 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07668284
The ClinicalTrials.gov registry entry for NCT07668284 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Coenzyme Q10 Cap/Tab is the first listed.
NCT07668284 reports 0 study locations.
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.
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