COQ10 and Vitamin E for Off-Target Radiation Toxicity

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Coenzyme Q10 Cap/Tab

    Drug

    taken daily for 3 months with vitamin E

  • Vitamin E Cap/Tab

    Drug

    taken daily for 3 months with CoQ10

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Arm I: TreatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 2 Dose

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

Time frame
3-6 months
2

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

Time frame
2-3 years

Secondary outcomes

1

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).

Time frame
2-3 years
2

Patient Quality of Life

To assess patient-reported quality of life using disease-specific EORTC surveys.

Time frame
2-3 years
3

Trajectory of Toxicity: Resolution

To characterize the resolution (persistence) of toxicity using patient reported outcome and adverse event data (time to event).

Time frame
2-3 years
4

Trajectory of Toxicity: Delayed Emergence

To characterize the delayed emergence of toxicity using patient reported outcome and adverse event data (time to event).

Time frame
2-3 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: