Could a common vitamin boost brain cancer treatment?
NCT ID NCT04677049
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests whether adding niacin (vitamin B3) to standard treatment (radiation and chemotherapy) can help people with newly diagnosed glioblastoma, an aggressive brain cancer. The trial has two phases: first, finding a safe dose of niacin, and second, checking if it improves survival at 6 months. About 59 adults aged 18-75 are being enrolled, but the trial is currently on hold.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Niacin (vitamin B3) controlled-release tablet
- What this could lead to
- If it works, this could point toward a way to improve survival for people with glioblastoma by adding a simple vitamin to standard therapy.
- What could go wrong
- This is an early-phase trial (phase I-II) with only 59 participants, so results may not apply broadly. The trial is currently suspended, and adding niacin may not improve outcomes or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 59 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2021
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults, 18 years old to 75 years old inclusive. * New diagnoses of glioblastoma IDH wild type. * ECOG 0-2 (Appendix I). * Candidates for concurrent standard first line treatment according to their Neuro-Oncologist and Radiotherapy Oncologist after maximal safe debulking neurosurgery. Patients that only had biopsy are included as long as pathology confirms the diagnoses and it is considered the maximal safe procedure for that patient. * Adequate hematological, renal and hepatic function (see details in Section 4.1 of the protocol). * Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection. * Absence of any other serious medical condition according to the medical judgment of the Qualified Investigator prior to registration. * Absence of any medical condition, which could interfere with oral medication intake. * Signed informed consent. * Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method. Exclusion Criteria: * Glioblastoma, IDH-mutant. * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Additionally, any low grade or low risk malignancy not requiring treatment will not exclude a patient from participation in the trial. * Known hypersensitivity to niacin. * Inability to provide informed consent. * Active liver disease or unexplained persistent elevations of serum transaminases. * Active peptic ulcer or active gastrointestinal bleeding. * Unstable angina or myocardial infarction within 6 months. * Symptomatic gout. * Patients on 3-hydroxy-3-methylglutaryl-coenzyme (HMG-COA reductase) inhibitors that cannot discontinue them at least 2 weeks before starting Niacin CRT™. * Any prior systemic treatment for glioblastoma (standard, evidence based or experimental) or radiotherapy/radiosurgery. * Individuals with MRI non-compatible metal in the body, or unable to undergo MRI procedures including allergy to gadolinium. * Patients unfit for any treatment component, including contraindications for radiotherapy or Connective Tissue Disease. * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial. * Pregnant, breast-feeding, unable and/or unwilling to use contraception methods.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
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Other studies related to the condition(s) this trial covers.
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