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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 19 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 90 days
- Procedures mentioned: Pills, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants must be able to swallow gel capsules."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether high-dose vitamin E and CoQ10 are safe and can reduce lasting side effects from radiation to the pelvis, the lower belly area. It is for adults treated for prostate, uterine, cervical, or anal cancer. Participants take both vitamins daily for 90 days.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 19 or older with cancer confirmed by a tissue test: prostate cancer after prostate removal, uterine cancer, cervical cancer, or anal cancer.
- Be scheduled for at least 15 radiation treatments aimed at curing cancer at the study site, with or without chemotherapy. The same area must not have had radiation before.
- Be able to care for yourself and be out of bed or a chair for at least half the day. Your doctor must expect you to live at least 6 months.
- Be able to swallow soft-gel pills and have no condition that greatly limits how your body absorbs medicine.
- Have blood tests showing enough blood cells and acceptable kidney, liver, and blood-clotting function.
- Agree to no more than 2 standard alcoholic drinks within 6 hours before and 6 hours after each vitamin dose.
- Stop other supplements containing vitamin E or CoQ10, and high-dose vitamin or mineral supplements, during the study and follow-up. Medically needed high doses may be allowed with study approval.
- Be able to follow study steps and give informed consent, yourself or through a legal representative. If you or your partner could become pregnant, agree to use two effective birth control methods, including one barrier method, until 1 month after the last vitamin dose.
Who can't join
- Receive less than 80% of the planned radiation, or be scheduled for SBRT or SRS, special types of highly focused radiation.
- Plan to take cancer drugs during the roughly 3 months of vitamin treatment after radiation, or receive other experimental treatments during the study.
- Need blood-thinning or anti-clotting medicine that cannot be stopped at least 2 weeks before study treatment and kept stopped until 1 month after treatment ends.
- Have a bleeding disorder, low vitamin K, liver or bile-system problems, severe tissue scarring, or retinitis pigmentosa, an eye disease that causes vision loss.
- Have a history of serious blood vessel disease in the brain, including stroke or bleeding in the brain, or uncontrolled blood pressure of 140/90 or higher.
- Have uncontrolled immune disease that destroys red blood cells or lowers platelets, an infection not controlled by treatment, or another uncontrolled illness that could affect safety or study results.
- Be allergic to vitamin E, CoQ10, soybean oil, soy lecithin, gelatin, or glycerin.
- Be pregnant or breastfeeding. People who could become pregnant must have a negative blood pregnancy test.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
NE
- University of Nebraska Medical Center · Omaha, NE 68198Erin M Drengler, MS · Study contact · 1 402 552 2435 · edrengler@unmc.eduTaylor A Johnson, MA · Study contact · 1 402 559 4596 · taylora.johnson@unmc.eduMore trials in Omaha