COQ10 and Vitamin E for Off-Target Radiation Toxicity

Evaluating the Safety and Efficacy of Coenzyme Q10 and Vitamin E Dual Therapy in Mitigating Chronic 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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer; Prostate Cancer; Anal Cancer; Uterine Cancer
• Intervention / Treatment: Drug: Coenzyme Q10 Cap/Tab; Drug: Vitamin E Cap/Tab

Detailed Description

The purpose of this study is to determine if high-dose supplementation with the antioxidants Coenzyme Q10 (ubidecarenone) and Vitamin E (dl-α-tocopherol) reduces subacute and chronic radiation-associated toxicity after radiation therapy for pelvic cancers including post-prostatectomy prostate, endometrial, cervical, and anal malignancies. Changes to oncologic outcomes will be assessed to characterize the effects of the vitamin regimen. The safety and tolerability of the vitamin regimen will be tested to determine the recommended phase II dose. Subsequently, the regimen's efficacy towards reducing the incidence and severity of post-treatment toxicity burden will be compared to historical norms. Other objectives of the research include characterizing the trajectory of recovery, patient reported quality of life outcomes, adherence to therapy, and longitudinal changes in biomarkers of oxidative stress.

Exposure to radiation can cause sustained oxidative stress, mitochondrial dysfunction, chronic inflammation, membrane injury, maladaptive tissue remodeling, and ferroptosis. The biological drivers of these effects may be counteracted by increasing the pool of active vitamin E (oxidized α-tocopherol) in affected tissues through perfusion and regeneration by CoQ10 (ubidecarenone as ubiquinol). The subject population will include adults with ECOG performance status ≤2 scheduled for curative-intent external beam radiation therapy ± chemotherapy as treatment for the pelvic malignancies listed above. Participants must be able to swallow gel capsules. Known comorbidities that affect vitamin absorption or tolerability, increase bleeding risk, and/or increase the risk of vitamin E overdose may exclude participation. Prior to the initiation of vitamin therapy, participants must complete at least 80% of their scheduled radiation dose and have adequate hematological, organ and clotting function. Pregnancy, lactation, and refusal of contraceptive precautions (unless exempt) preclude participation.

Research interventions include daily co-administration of vitamin E (450-900 mg) and CoQ10 (100-200 mg) for 90 days immediately following radiation therapy, frequent clinic visits and phlebotomy, PRO questionnaires, and the collection of blood-based research specimens. The duration of participation will vary with the length of radiation therapy but will always involve a 3-month treatment period followed by 21 months of follow up.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Erin M Drengler, MS; Phone Number: 1 402 552 2435; Email: edrengler@unmc.edu
• Study Contact Backup: Name: Taylor A Johnson, MA; Phone Number: 1 402 559 0963; Email: taylora.johnson@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
      • Contact: Erin M Drengler, MS; Phone Number: 1 402 552 2435; Email: edrengler@unmc.edu
      • Contact: Taylor A Johnson, MA; Phone Number: 1 402 559 4596; Email: taylora.johnson@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically confirmed post-prostatectomy prostate, uterine (endometrial and cervical), or anal cancer.
2. 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.
3. Age ≥ 19 years at the time of consent.
4. Eastern Cooperative Oncology Group Performance Status ≤ 2.
5. Life expectancy ≥ 6 months at the time of consent as determined by the participant's treating physician.
6. Participants must be able to swallow soft-gel capsules.
7. 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).
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.

13. 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.
    • Calculated creatinine clearance (CrCl (mL/min); Cockcroft-Gault formula) ≥ 30 mL/min.
    • Total bilirubin ≤ 1.5X institutional upper limit of normal (ULN) or ≤3 X ULN for patients with known Gilbert's syndrome
    • AST (SGOT) and ALT (SGPT) ≤ 3X institutional ULN
    • PT/INR and PTT (in the absence of lupus anticoagulant) ≤ 2X institutional ULN.

Exclusion Criteria:

1. Participants who do not receive ≥ 80% of the planned total radiation.
2. Participants who are scheduled to receive SBRT/SRS
3. Participant's treatment plan must not include anti-cancer pharmaceutical therapies during the period of vitamin administration (~3 months after completion of radiation therapy).
4. Participants must not receive any other investigational agents while on study.

5. Participants must not have contraindications to Vitamin E or CoQ10 supplementation, including:

   1. 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.
   2. Underlying bleeding conditions (e.g., hemophilia or von Willebrand disease)
   3. Retinitis pigmentosa
   4. Hepatobiliary dysfunction
   5. Vitamin K deficiency
   6. Preexisting severe fibrosis
   7. History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage.
   8. Uncontrolled Grade 2 hypertension defined as ≥ 140 mm Hg systolic blood pressure or ≥ 90 mm Hg diastolic blood pressure.
   9. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).
   10. Uncontrolled systemic bacterial, fungal, parasitic, mycobacterial, viral, or other infections, despite appropriate antibiotics or other treatments.
   11. Any other uncontrolled comorbidities that, in the opinion of the treating investigator, would compromise subject safety or study outcomes.
6. Participant must not have a history of allergic reactions to Vitamin E or CoQ10 or any of the vitamin excipients (soybean oil, soy lecithin, gelatin, glycerin).
7. Not pregnant or lactating. A negative pregnancy test (serum hCG) is required for participants of childbearing potential. Female participants who are permanently sterilized (hysterectomy/bilateral oophorectomy) or postmenopausal (12 months of consecutive amenorrhea, > 45 years-of-age in the absence of other biological or physiological causes; females < 55 years-of-age with serum FSH level > 40 mIU/mL) are exempt

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I: Treatment; 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; taken daily for 3 months with vitamin E; Other Names: ubidecarenone; Drug: Vitamin E Cap/Tab; taken daily for 3 months with CoQ10; Other Names: dl-α-tocopherol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin Safety and Tolerability	To further characterize the safety and tolerability of post-radiation vitamin E and CoQ10 supplementation through clinician-reported adverse events (CTCAE v5.0).	2-3 years
Patient Quality of Life	To assess patient-reported quality of life using disease-specific EORTC surveys.	2-3 years
Trajectory of Toxicity: Resolution	To characterize the resolution (persistence) of toxicity using patient reported outcome and adverse event data (time to event).	2-3 years
Trajectory of Toxicity: Delayed Emergence	To characterize the delayed emergence of toxicity using patient reported outcome and adverse event data (time to event).	2-3 years
Oncologic Safety: Recurrence/Progression Free Survival	To describe patterns of recurrence/progression during follow-up to monitor for unexpected oncologic safety signals (time to event).	2-3 years
Oncologic Safety: Overall Survival	To describe patterns of survival during follow-up to monitor for unexpected oncologic safety signals (time to event).	2-3 years

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Chi P Lin, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 15, 2030
• Study Completion (Estimated): December 15, 2030

Study Registration Dates

• First Submitted: June 6, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: subacute; radiation; antioxidant; toxicity
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Anus Diseases; Rectal Neoplasms; Prostatic Neoplasms; Uterine Cervical Neoplasms; Anus Neoplasms; Uterine Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Benzopyrans; Tocopherols; Vitamin E; alpha-Tocopherol; coenzyme Q10
• Other Study ID Numbers: COQ10VERT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No