COQ10 and Vitamin E for Off-Target Radiation Toxicity

NCT07668284 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: COQ10VERT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Cervical Cancer; Anal Cancer; Uterine Cancer

Keywords

radiation; toxicity; subacute; antioxidant

Outcome Measures

Primary Outcomes (2)

• Recommended Phase 2 Dose

  Determine if the initial dose of each vitamin is recommended for the remainder of study participants.

  3-6 months

• Incidence of Grade ≥2 (CTCAE) Radiation-Associated Toxicity

  The incidence of CTCAE Grade ≥2 radiation therapy-associated toxicity occurring from completion of RT through 3 months post-RT

  2-3 years

Secondary Outcomes (6)

• Vitamin Safety and Tolerability

  2-3 years

• Patient Quality of Life

  2-3 years

• Trajectory of Toxicity: Resolution

  2-3 years

• Trajectory of Toxicity: Delayed Emergence

  2-3 years

• Oncologic Safety: Recurrence/Progression Free Survival

  2-3 years

Study Arms (1)

Arm I: Treatment

EXPERIMENTAL

Vitamin E (dl-α-tocopherol), gel capsule, 900 mg, QD, 90 days CoQ10 (ubidecarenone), gel capsule, 200 mg, QD, 90 days The vitamins are co-administered.

Drug: Coenzyme Q10 Cap/Tab; Drug: Vitamin E Cap/Tab

Interventions

Coenzyme Q10 Cap/Tab DRUG

taken daily for 3 months with vitamin E

Also known as: ubidecarenone

Arm I: Treatment

Vitamin E Cap/Tab DRUG

taken daily for 3 months with CoQ10

Also known as: dl-α-tocopherol

Arm I: Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed post-prostatectomy prostate, uterine (endometrial and cervical), or anal cancer.
• Scheduled for curative-intent, multi-fraction (at least 15 fractions) external-beam radiotherapy +/- chemotherapy at the study site which does not involve re-irradiation to the same field.
• Age ≥ 19 years at the time of consent.
• Eastern Cooperative Oncology Group Performance Status ≤ 2.
• Life expectancy ≥ 6 months at the time of consent as determined by the participant's treating physician.
• Participants must be able to swallow soft-gel capsules.
• Participants must not have a disease significantly affecting drug absorption (e.g., resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction).
• Participants must agree to limit alcohol consumption to ≤ 2 standard drinks (14 g of pure ethanol) within 6 hours before and 6 hours after vitamin administration.
• Participants must agree to discontinue current vitamin/mineral supplements, including multivitamins, that contain Vitamin E (α-tocopherol) or CoQ10 (ubidecarenone) and abstain from taking these supplements while on study, including during the follow-up period. Participants must also agree to discontinue and abstain from high-dose vitamin/mineral supplementation while on-study and during the study follow-up period. NOTE: Participants for whom high-dose vitamin/mineral supplementation is medically necessary are eligible if the principal investigator determines that continuing treatment will not impact safety or study outcomes.
• Women of childbearing potential and male participants with partners of childbearing potential must agree to use two forms of medically effective contraception (at least one of which must be a barrier method) while on study until one month following the last dose of vitamin supplements.
• As determined by the enrolling physician, the participant must be able to understand and comply with study procedures for the entire length of the study. There must not be psychological, familial, sociological, or geographical conditions potentially hampering protocol compliance, including alcohol dependence or drug abuse.
• The participant or the participant's legally authorized representative must provide documented informed consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
• Participant must have adequate hematological, organ, and clotting function as defined below. Screening labs must be obtained prior to the end of radiation therapy.
• Absolute Neutrophil Count (ANC) ≥ 500/mm3
• Platelets ≥ 50,000/mm3 • Hemoglobin ≥ 8.0 g/dL. The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.

You may not qualify if:

• Participants who do not receive ≥ 80% of the planned total radiation.
• Participants who are scheduled to receive SBRT/SRS
• Participant's treatment plan must not include anti-cancer pharmaceutical therapies during the period of vitamin administration (\~3 months after completion of radiation therapy).
• Participants must not receive any other investigational agents while on study.
• Participants must not have contraindications to Vitamin E or CoQ10 supplementation, including:
• Anticoagulation or antiplatelet therapy that cannot be stopped. NOTE: To be eligible, participants must be able to discontinue contraindicated medications at least 2 weeks prior to the initiation of study treatment. These medications may be resumed 1 month after completing study treatment.
• Underlying bleeding conditions (e.g., hemophilia or von Willebrand disease)
• Retinitis pigmentosa
• Hepatobiliary dysfunction
• Vitamin K deficiency
• Preexisting severe fibrosis
• History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage.
• Uncontrolled Grade 2 hypertension defined as ≥ 140 mm Hg systolic blood pressure or ≥ 90 mm Hg diastolic blood pressure.
• Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).
• Uncontrolled systemic bacterial, fungal, parasitic, mycobacterial, viral, or other infections, despite appropriate antibiotics or other treatments.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Uterine Neoplasms; Uterine Cervical Neoplasms; Anus Neoplasms

Interventions

coenzyme Q10; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Cervical Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chi P Lin, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin M Drengler, MS

CONTACT

1 402 552 2435; edrengler@unmc.edu

Taylor A Johnson, MA

CONTACT

1 402 559 0963; taylora.johnson@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)