Prostate CancerPhase 1/2NCT07668284
COQ10 and Vitamin E for Off-Target Radiation Toxicity
A Phase 1/2 study testing Coenzyme Q10 Cap/Tab and Vitamin E Cap/Tab in people with Prostate Cancer and Uterine Cancer, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Prostate Cancer, Uterine Cancer, Cervical Cancer
- What is being tested?
- Coenzyme Q10 Cap/Tab and Vitamin E Cap/Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 15 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Any other uncontrolled comorbidities that, in the opinion of the treating investigator, would compromise subject safety or study outcomes.
- 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).
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Erin M Drengler, MS, 1 402 552 2435, edrengler@unmc.edu
Taylor A Johnson, MA, 1 402 559 4596, taylora.johnson@unmc.edu
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Prostate Cancer, Uterine Cancer, Cervical Cancer, Anal Cancer
- Being tested
- Coenzyme Q10 Cap/Tab, Vitamin E Cap/Tab
- Keywords
- radiation, toxicity, subacute, antioxidant
- Medical subject headings
- Prostatic Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 Cap/TabDrug
Also called ubidecarenone
taken daily for 3 months with vitamin E
Vitamin E Cap/TabDrug
Also called dl-α-tocopherol
taken daily for 3 months with CoQ10
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Coenzyme Q10 Cap/Tab; Drug: Vitamin E Cap/Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose
Determine if the initial dose of each vitamin is recommended for the remainder of study participants.
Measured: 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
Measured: 2-3 years
Secondary outcomes (6)
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).
Measured: 2-3 years
Patient Quality of Life
To assess patient-reported quality of life using disease-specific EORTC surveys.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion15 Feb 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi P Lin, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668284
- Sponsor's protocol ID
- COQ10VERT
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Coenzyme Q10 and Vitamin E Dual Therapy in Mitigating Chronic Off-Target Radiation Toxicity
- ClinicalTrials.gov ID
- NCT07668284
- Acronym / sponsor ID
- COQ10VERT
- Conditions
- Prostate Cancer, Uterine Cancer, Cervical Cancer, Anal Cancer
- Keywords
- radiation, toxicity, subacute, antioxidant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 15 Feb 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I: Treatment | Experimental | Drug: Coenzyme Q10 Cap/Tab, Drug: Vitamin E Cap/TabVitamin 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10 Cap/TabAlso: ubidecarenonetaken daily for 3 months with vitamin E | Drug | Arm I: Treatment |
| Vitamin E Cap/TabAlso: dl-α-tocopheroltaken daily for 3 months with CoQ10 | Drug | Arm I: Treatment |
Primary outcome
Recommended Phase 2 Dose
Time frame: 3-6 months
Determine if the initial dose of each vitamin is recommended for the remainder of study participants.
Incidence of Grade ≥2 (CTCAE) Radiation-Associated Toxicity
Time frame: 2-3 years
The incidence of CTCAE Grade ≥2 radiation therapy-associated toxicity occurring from completion of RT through 3 months post-RT
6 secondary outcomes
Vitamin Safety and Tolerability
Time frame: 2-3 years
Patient Quality of Life
Time frame: 2-3 years
Trajectory of Toxicity: Resolution
Time frame: 2-3 years
Trajectory of Toxicity: Delayed Emergence
Time frame: 2-3 years
Oncologic Safety: Recurrence/Progression Free Survival
Time frame: 2-3 years
Oncologic Safety: Overall Survival
Time frame: 2-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi P Lin, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coenzyme Q10 Cap/Tab and Vitamin E Cap/Tab in people with Prostate Cancer and Uterine Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin M Drengler, MS (1 402 552 2435, edrengler@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.