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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Coenzyme Q10 Cap/Tab
Drugtaken daily for 3 months with vitamin E
Vitamin E Cap/Tab
Drugtaken daily for 3 months with CoQ10
Treatment groups
Trial outcomes
Primary outcomes
Recommended Phase 2 Dose
Determine if the initial dose of each vitamin is recommended for the remainder of study participants.
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
Secondary outcomes
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).
Patient Quality of Life
To assess patient-reported quality of life using disease-specific EORTC surveys.
Trajectory of Toxicity: Resolution
To characterize the resolution (persistence) of toxicity using patient reported outcome and adverse event data (time to event).
Trajectory of Toxicity: Delayed Emergence
To characterize the delayed emergence of toxicity using patient reported outcome and adverse event data (time to event).
Sponsors and contacts
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