CoQ10 Supplement for Glioblastoma

Overseen By Priya Yerraballa

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Insulin

Disqualifiers: Refuse IV, Allergy MRI contrasts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Varies

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM).

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but if you are diabetic and taking insulin, you cannot participate.

Is CoQ10 safe for use in humans, particularly in the context of glioblastoma treatment?

CoQ10, also known as BPM31510, has been studied for its safety in humans, showing potential to improve the tolerability of cancer treatments and selectively target cancer cells without harming non-cancer cells. It has been used in various studies, including those involving glioblastoma, with no major safety concerns reported. ^{1 2 3 4 5}

How does CoQ10 differ from other treatments for glioblastoma?

CoQ10 is unique because it can cross the blood-brain barrier and acts as an antioxidant, helping to reduce tumor growth and invasion by remodeling proteins and inhibiting blood vessel formation and inflammation. Unlike standard treatments, CoQ10 also enhances the effectiveness of temozolomide, a common chemotherapy drug, by increasing the cancer cells' sensitivity to it. ^{1 2 3 4 6}

What evidence supports the effectiveness of the CoQ10 supplement treatment for glioblastoma?

Research suggests that CoQ10 can reduce glioblastoma growth and invasion by acting as an antioxidant and improving the effectiveness of standard treatments like temozolomide. It may also help in reducing the spread of cancer cells and improving the body's response to treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Lawarence Recht

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with Glioblastoma who can consent to the study and are part of a Phase II trial for BPM31510. Women able to have children must test negative for pregnancy. It's not suitable for insulin-dependent diabetics, those who refuse IVs, or people allergic to MRI contrast agents.

Inclusion Criteria

Ability to understand and the willingness to provide written informed consent.

Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)

I am capable of becoming pregnant and have a negative pregnancy test.

Exclusion Criteria

I am diabetic and take insulin.

I refuse to receive treatments through an IV.

Allergy to MRI contrasts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BPM31510, a lipid nano dispersion of CoQ10, along with standard treatment for Glioblastoma. They will also undergo metabolic imaging with deuterated glucose and MRI.

Varies

1 visit for MRI and DMI study

Follow-up

Participants are monitored for overall survival and progression-free survival.

up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• BPM31510

Trial Overview The study aims to assess how well DMI (using [6,6-²H₂]-Glucose) predicts treatment success when adding BPM31510 (a CoQ10 lipid nano dispersion) to standard GBM therapy.

How Is the Trial Designed?

Group I: Deuterated Glucose + MRI Experimental Treatment 1 Intervention

Participants will receive \[6,6-²H₂\]-glucose orally at a dose of 0.75g per kg of body weight (maximum 60g), dissolved in 200-500mL of water. Approximately 45 minutes after ingestion, participants will undergo an MRI scan consisting of a 30-minute conventional MRI brain study followed by a 1-hour Deuterium Metabolic Imaging (DMI) study. A Gadolinium contrast agent may be administered if more than 4 weeks have passed since the last enhanced MRI scan.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Coenzyme Q10 (CoQ10) significantly reduced tumor volume in glioblastoma multiforme (GBM) models by decreasing hypoxia and vascularization, while also limiting inflammatory cell infiltration.

CoQ10's effects on GBM were linked to the downregulation of key proteins like HIF-1α and NF-kB, leading to changes in tumor cell behavior, including reduced migration and invasion, suggesting it could be a valuable addition to current GBM therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CoQ10 reduces glioblastoma growth and infiltration through proteome remodeling and inhibition of angiogenesis and inflammation. Frontiñán-Rubio, J., Llanos-González, E., García-Carpintero, S., et al.[2023]

A systematic review of six studies, including three randomized trials, suggests that oral supplementation with coenzyme Q10 (CoQ10) may help protect against cardiotoxicity or liver toxicity in cancer patients undergoing treatment, particularly those receiving anthracyclines.

However, the evidence is not conclusive due to inadequate reporting and questionable validity of outcome measures, indicating a need for more rigorous trials to confirm the efficacy of CoQ10 in improving the tolerability of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 for improved tolerability of cancer treatments: a systematic review. Roffe, L., Schmidt, K., Ernst, E.[2022]

Coenzyme Q10 (CoQ10) enhances the effectiveness of temozolomide (TMZ) in treating chemoresistant glioblastoma cells by increasing sensitivity and reducing cell proliferation, as demonstrated in a study using a TMZ-resistant rat glioma cell line.

CoQ10 not only improves the cytotoxic effects of TMZ but also suppresses glioma cell invasion by inhibiting key proteins involved in cell migration, suggesting it could be a valuable addition to standard glioblastoma therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Antioxidant Potential with Coenzyme Q10 Suppressed Invasion of Temozolomide-Resistant Rat Glioma In Vitro and In Vivo. Burić, SS., Podolski-Renić, A., Dinić, J., et al.[2020]

Endogenous coenzyme Q10 (CoQ10) levels were found to be higher in non-tumor brain tissues compared to all grades of astrocytoma, indicating a potential deficiency in CoQ10 as the tumor malignancy increases.

Several COQ proteins essential for CoQ10 biosynthesis were significantly lower in Grade IV astrocytoma tissues, suggesting that mitochondrial dysfunction and impaired CoQ10 maintenance may contribute to the progression of this type of brain cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levels of Coenzyme Q10 and Several COQ Proteins in Human Astrocytoma Tissues Are Inversely Correlated with Malignancy. Yen, HC., Chen, BS., Yang, SL., et al.[2022]

Coenzyme Q10 enhances the growth and viability of glioma cells in serum-free conditions by restoring mitochondrial function and increasing energized mitochondria.

The mechanism behind this effect involves a decrease in intracellular reduced glutathione, which activates key signaling pathways including proteinkinase C, ERK1/2, and phosphoinositol-3-kinase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLIOMA CELL PROLIFERATION MEDIATED BY COENZYME Q10 AT SERUM DEPRIVATION IN VITRO. Krylova, NG., Kulahova, TA., Koren, SV., et al.[2018]

Ubidecarenone, delivered through BPM31510, shows a significant therapeutic potential against glioblastoma, as it selectively targets cancer cells with elevated oxidative stress, leading to increased sensitivity compared to non-cancer cells.

In vivo studies demonstrated that treatment with ubidecarenone resulted in over 25% long-term survival in a rodent glioma model, indicating its effectiveness in enhancing survival in aggressive cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High levels of ubidecarenone (oxidized CoQ10) delivered using a drug-lipid conjugate nanodispersion (BPM31510) differentially affect redox status and growth in malignant glioma versus non-tumor cells. Sun, J., Patel, CB., Jang, T., et al.[2021]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

CoQ10 reduces glioblastoma growth and infiltration through proteome remodeling and inhibition of angiogenesis and inflammation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 for improved tolerability of cancer treatments: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Modulation of Antioxidant Potential with Coenzyme Q10 Suppressed Invasion of Temozolomide-Resistant Rat Glioma In Vitro and In Vivo. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Levels of Coenzyme Q10 and Several COQ Proteins in Human Astrocytoma Tissues Are Inversely Correlated with Malignancy. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

GLIOMA CELL PROLIFERATION MEDIATED BY COENZYME Q10 AT SERUM DEPRIVATION IN VITRO. [2018]

6. England pubmed.ncbi.nlm.nih.gov

High levels of ubidecarenone (oxidized CoQ10) delivered using a drug-lipid conjugate nanodispersion (BPM31510) differentially affect redox status and growth in malignant glioma versus non-tumor cells. [2021]