Could a milk thistle extract help fight brain cancer?
NCT ID NCT06964815
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding silibinin (a milk thistle extract) to standard chemoradiation and maintenance chemotherapy can delay tumor growth in people with a specific type of newly diagnosed glioblastoma. About 110 adults whose tumors have a certain protein marker (STAT3-positive) will be randomly assigned to receive either silibinin or a placebo alongside their usual treatment. The main goal is to see if silibinin extends the time before the cancer progresses.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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: * New histologically confirmed diagnosis of glioblastoma (WHO 2021) * Local availability of MGMT methylation status * Immunohistochemical positivity of activated STAT3 (pSTAT3) expression on the tumor tissue sample. STAT3 expression will be evaluated centrally by UOC Anatomia Patologica of Azienda Ospedale Università di Padova. * Chemoradiotherapy start within 7 weeks from surgery * Patients without disease progression after surgery * Availability of paraffin-embedded tumor tissue * Age ≥18 years * ECOG PS 0-2; Karnofsky 100-70 * Signing of informed consent prior to any study procedure * Patients (both males and females) should employ adequate contraceptive measures, which should be maintained during the whole duration of the trial (from screening to 6 months after the last dose of Temozolomide). * Have adequate bone marrow, liver and kidney function, as measured by the following laboratory assessments conducted within 10 days before the start of study treatment: * Hemoglobin \> 9.0 g/dl * Absolute neutrophil count (ANC) ≥1500/mm3 without granulocyte colony-stimulating factor (G-CSF) and other hematopoietic growth factors * Platelet count ≥100,000/μl * WBC ≥3.0 x 10 9 /L * Total bilirubin \<1.5 times the upper limit of normal * ALT and AST \<3 x the upper limit of normal * Serum creatinine \<1.5 times the upper limit of normal * Glomerular filtration rate ≥ 30 mL/min/1.73 m2 according to the abbreviated formula Modified Diet in Renal Disease * Alkaline phosphatase \<2.5 x ULN * PT-INR/PTT \<1.5 x upper limit of normal (patients who are therapeutically anticoagulated with anticoagulant drugs will be able to participate provided there is no history of abnormal background in these parameters, based on history). * Complete urinalysis * Stable and decreasing corticosteroid dosage in the last 10 days before brain MRI Exclusion Criteria: * Patients diagnosed with glioblastoma (WHO grade IV 2021) who have only had a diagnostic biopsy * Chemotherapy, immunotherapy, or antineoplastic therapy for glioblastoma * Negative immunohistochemistry of STAT3 expression on the tumor tissue sample * Diagnosis of another tumor or secondary brain localization * In the investigator's judgment, any evidence of severe or uncontrolled systemic disease including: uncontrolled hypertension; hemorrhagic diathesis; active infection with HBV, HCV, HIV. Screening for such chronic conditions is not required by the protocol; bone marrow reserve or organ dysfunction as demonstrated by laboratory tests. * Patients who are unable to comply with study procedures and requirements. * Contraindication to Brain MRI * Pregnant or breastfeeding patients * Patients who are unable to swallow capsules or sachets dissolved in water. * Patient unable to sign the Informed Consent * Glioblastoma leptomeningeal dissemination * Congestive heart failure classified as New York Heart Association (NYHA) Class 2 or higher; Unstable angina (symptoms of angina at rest) or new onset angina ≤3 months prior to screening; myocardial infarction \<6 months prior to 'start of study treatment; cardiac arrhythmias requiring antiarrhythmic therapy, with the exception of beta-blockers or digoxin; uncontrolled hypertension (systolic blood pressure \[SBP\]\>140 mmHg or diastolic blood pressure \[DBP\] \>90 mmHg) despite optimal medical management. * Arterial thrombotic or embolic events such as stroke and/or transient ischemic attacks) or * Pulmonary embolism in the 6 months prior to the start of study treatment * Ongoing infection with grade 2 or higher severity (NCI-CTCAE v 5.0) * Known history of human immunodeficiency virus (HIV) infection; hepatitis B or C active or chronic requiring treatment with antiviral therapy * History of organ allotransplantation * Evidence or history of any bleeding diathesis (including mild hemophilia), regardless of its severity; * Injuries, ulcers or bone fractures that have not fully resolved. * Renal failure requiring hemodialysis or peritoneal dialysis * Presenting interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained. * Persistent proteinuria \>3.5 g/24 hours as measured by urinary protein-creatinine ratio from a urine sample (≥ Grade 3, NCI-CTCAE v 5.0). CTCAE 5.0 is also available in Appendix 1.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ARNAS G.Brotzu P.O Armando Businco
NOT_YET_RECRUITINGCagliari, Italy/Cagliari, 09047, Italy
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Azienda Ospedaliera Universitaria - Careggi
NOT_YET_RECRUITINGFlorence, Italia/FI, 50134, Italy
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Azienda Ospedaliera Universitaria G.Martino
NOT_YET_RECRUITINGMessina, ME, 98124, Italy
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Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco "
NOT_YET_RECRUITINGCatania, Italia/Catania, 95123, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITINGRoma, RM, Italy
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Humanitas Cancer Center
NOT_YET_RECRUITINGMilan, 20089, Italy
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IRCCS Istituto delle Scienze Neurologiche di Bologna
NOT_YET_RECRUITINGBologna, BO, 40139, Italy
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IRCCS Ospedale Galeazzi Sant'Ambrogio
NOT_YET_RECRUITINGMilan, 20157, Italy
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IRST Dino Amadori
NOT_YET_RECRUITINGMeldola, FC, 47014, Italy
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Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Fondazione Mondino
NOT_YET_RECRUITINGPavia, Italy/Pavia, 27100, Italy
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Istituto Oncologico Veneto
RECRUITINGPadova, Italy/Padova, 35128, Italy
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Istituto Tumori Regina Elena IRCCS
NOT_YET_RECRUITINGRoma, RM, 00128, Italy
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Ospedale A. Manzoni Lecco
NOT_YET_RECRUITINGLecco, 23900, Italy
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Ospedale del Mare, ASL Napoli1 Centro
NOT_YET_RECRUITINGNaples, italy/Napoli, 80147, Italy
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Policlinico San Martino - Genova
NOT_YET_RECRUITINGGenova, Italy
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USL Nord Ovest Toscana - Livorno
NOT_YET_RECRUITINGLivorno, Italy/Livorno, 57124, Italy
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