NOT_YET_RECRUITING

Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection

Conditions

Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities Mixed toxic chemicals Chronic multisymptom illness Train derailment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is being conducted to see if coenzyme Q10 (a nutritional supplement) might help to prevent and/or alleviate symptoms and health consequences and help to improve quality of life and physical function in residents affected by the February 2023 East Palestine, Ohio train derailment. This is a pilot study that is not powered to achieve benefit but seek to examine effect size and variance to aid in power calculations for a potential future better powered study.

Official Title

Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection

Quick Facts

Study Start:2025-07-01

Study Completion:2028-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:NOT_YET_RECRUITING

Study ID

NCT06962657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* On Feb. 3, 2023, lived within 10 miles of the East Palestine, OH train derailment (closer in will receive preference). Others who were in the area for toxin mitigation and other reasons and show compatible symptoms will also be eligible. * Meets Kansas symptom criteria for multi-symptom illness - originally defined for Gulf War Illness (has persistent symptoms, lasting greater than six months, that are of \>mild severity in at least three of the six domains of fatigue/sleep, pain, neurological/cognitive/mood, gastrointestinal, respiratory and dermatologic). At least some symptoms must be new or worsened since the derailment. * Access to internet and smart phone or computer for remote Qualtrics survey participation. * Willing to perform the stipulated study elements. * Took ≥80% of run-in soft gels.	* Anticipated move from the area or other anticipated obstacle to participating for study duration. * Participating in another clinical trial. * Has a pre-existing health condition expected to produce significant and variable fluctuating symptoms (e.g. chronic infection and/or active cancer other than non-melanoma skin cancer). * Contraindications to CoQ10, such as use of coumadin (although an interaction with CoQ10 is controversial).

Inclusion Criteria

Exclusion Criteria

* On Feb. 3, 2023, lived within 10 miles of the East Palestine, OH train derailment (closer in will receive preference). Others who were in the area for toxin mitigation and other reasons and show compatible symptoms will also be eligible.
* Meets Kansas symptom criteria for multi-symptom illness - originally defined for Gulf War Illness (has persistent symptoms, lasting greater than six months, that are of \>mild severity in at least three of the six domains of fatigue/sleep, pain, neurological/cognitive/mood, gastrointestinal, respiratory and dermatologic). At least some symptoms must be new or worsened since the derailment.
* Access to internet and smart phone or computer for remote Qualtrics survey participation.
* Willing to perform the stipulated study elements.
* Took ≥80% of run-in soft gels.

* Anticipated move from the area or other anticipated obstacle to participating for study duration.
* Participating in another clinical trial.
* Has a pre-existing health condition expected to produce significant and variable fluctuating symptoms (e.g. chronic infection and/or active cancer other than non-melanoma skin cancer).
* Contraindications to CoQ10, such as use of coumadin (although an interaction with CoQ10 is controversial).

Contacts and Locations

Study Contact

Janis B. Ritchie, BSN

CONTACT

858-558-4950

jbritchie@ucsd.edu

Principal Investigator

Beatrice A. Golomb, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

UC San Diego

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Beatrice A. Golomb, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01

Study Completion Date2028-07-01

Study Record Updates

Study Start Date2025-07-01

Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

Mixed toxic chemicals
Chronic multisymptom illness
Train derailment

Additional Relevant MeSH Terms

Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities