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COQ10 and Vitamin E for Off-Target Radiation Toxicity

NCT07668284 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-25

No results posted yet for this 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.

Conditions

Interventions

DRUG

Coenzyme Q10 Cap/Tab

taken daily for 3 months with vitamin E

DRUG

Vitamin E Cap/Tab

taken daily for 3 months with CoQ10

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Chi P Lin, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2030-02-15
Completion
2030-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668284 on ClinicalTrials.gov