CoQ10 + Vitamin E for Radiation Side Effects in Cancer

EM
TA
Overseen ByTaylor A Johnson, MA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether high doses of Vitamin E (dl-α-tocopherol acetate) and CoQ10 (Coenzyme Q10, or ubidecarenone) can reduce side effects after radiation treatment for prostate, uterine, cervical, or anal cancer. The researchers aim to determine if this combination can ease symptoms and improve quality of life without impacting cancer treatment outcomes. Eligible participants should have completed surgery for one of these cancers and be scheduled for radiation therapy. Participants will take the vitamins daily for 90 days and attend regular checkups, including blood tests and scans. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's effects and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in cancer care.

Is there any evidence suggesting that taking high doses of Vitamin E and CoQ10 is safe and tolerable?

Studies have shown that Coenzyme Q10 (CoQ10) and Vitamin E are safe for many people. Research suggests that CoQ10 might reduce side effects from cancer treatments, particularly those affecting the heart and liver, indicating it is generally well-tolerated.

Vitamin E is a common supplement that many people use without problems. In the higher doses used in this trial, monitoring for any unusual side effects is important, but past studies have not reported any major safety issues.

Overall, these supplements are considered safe, but this trial aims to confirm their safety for people undergoing cancer treatment.1234

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for radiation side effects in cancer, which often focus on symptom management using medications or steroids, the combination of Coenzyme Q10 and Vitamin E offers a unique approach by potentially protecting cells from oxidative damage. Coenzyme Q10 and Vitamin E are both powerful antioxidants, and their role in this treatment is to minimize the harmful effects of radiation on healthy cells. Researchers are excited about this treatment because if successful, it could provide a more natural and preventative strategy to managing radiation side effects, rather than just treating symptoms after they occur.

What evidence suggests that this treatment might be an effective treatment for radiation side effects in cancer?

Research has shown that taking Vitamin E and CoQ10 together might help lessen the side effects of radiation. In this trial, participants will receive a combination of these supplements. Vitamin E acts as an antioxidant, protecting cells from radiation damage. CoQ10 aids in energy production and also functions as an antioxidant, potentially reducing harmful effects. Studies suggest that using both together is more effective than using each one alone. So far, no serious side effects have been reported with CoQ10, making it a promising option for support during treatment.56789

Who Is on the Research Team?

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Chi P Lin, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults who have received pelvic radiation for prostate, uterine, cervical, or anal cancer. Participants must be able to take oral supplements and agree to regular clinic visits and blood tests. People with conditions that prevent vitamin absorption or those unable to follow the study schedule may not qualify.

Inclusion Criteria

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
Life expectancy ≥ 6 months at the time of consent as determined by the participant's treating physician
Participant or legally authorized representative must provide documented informed consent after being informed of study procedures, experimental nature, alternatives, potential benefits, side effects, risks, and discomforts
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Exclusion Criteria

History of allergic reactions to Vitamin E, CoQ10, or vitamin excipients (soybean oil, soy lecithin, gelatin, glycerin)
My treatment plan includes anti-cancer drugs during the vitamin period after radiation.
Participants receiving other investigational agents while on study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily co-administration of Vitamin E and CoQ10 for 90 days immediately following radiation therapy

12 weeks
Clinic visits every 2-4 weeks

Follow-up

Participants are monitored for safety, efficacy, and quality of life impacts after treatment

21 months
Clinic visits every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Coenzyme Q10 (ubidecarenone)
  • Vitamin E (dl-α-tocopherol acetate)

Trial Overview

The study is testing if taking high doses of Vitamin E (900mg) and CoQ10 (200mg) daily for 90 days can safely reduce long-term side effects from pelvic radiation in cancer patients. All participants will receive both vitamins by mouth.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Arm I: TreatmentExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Citations

Is it Possible that combined Alpha-tocopherol and CoQ10 ...

The data further revealed that the combined treatment of Vitamin E, Coenzyme Q10 is more effective than the treatment of these antioxidants ...

EVS Explore - C916 - Ubidecarenone - National Cancer Institute

Coenzyme Q10 helps mitochondria (small structures in the cell) make energy. It is an antioxidant that helps prevent cell damage caused by free radicals (highly ...

Vitamin E: Tocopherols and tocotrienols as potential ...

Vitamin E is a well-known antioxidant, effective in scavenging free radicals generated by radiation exposure.

Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post ...

This research study is being conducted to see if coenzyme Q10 (a nutritional supplement) might help to prevent and/or alleviate symptoms and ...

role of coenzyme q10 in current oncology practice

CoQ10 therapy has no serious side effects in humans and new formulations have been developed that increase CoQ10 absorption and tissue ...

https://portal.gdc.cancer.gov/files/12f05d0c-b29f-...

CoQ10: A Supportive Supplement Increasingly Trusted by ...

CoQ10 may help reduce cancer-treatment side effects—especially heart and liver toxicity. For those actively fighting cancer, anything

https://www.fda.gov/node/377586

No information is available for this page.

Can coenzyme Q10 (CoQ10) be used in patients with ...

Some studies suggest that CoQ10 may provide protection against cardiotoxicity or liver toxicity during cancer treatment, but the results are not ...