Menu
Not yet recruiting NCT06750458

Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients

Phase III Interventional Glioma Dapagliflozin (Forxiga) Dexamethasone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin placebo, Placebo, DexamethasoneGroup III (n=25) (Dexamethasone group).
Who it may be relevant to
Registry conditions: Glioma, Dapagliflozin (Forxiga), Dexamethasone. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients

Overview

The aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug.

Detailed description

* This is a randomized, parallel, and controlled study, which will be conducted on pre-operative non-diabetic glioma patients on levetiracetam as anti-seizure drug. \* This study will be conducted pending registration at ClinicalTrials.gov. * All patients will give their written informed consents. * Data of patients will be confidential. * Any unexpected risk will be reported to patients and Ethical Committee on time. \* Randomization will be carried out based on days on hospital admission.

Interventions

  • Drug Dapagliflozin placebo
    Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dapagliflozin 10 mg once daily for 14 days pre-operative
  • Drug Placebo
    Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive placebo tablets once daily for 14 days pre-operative.
  • Drug DexamethasoneGroup III (n=25) (Dexamethasone group)
    Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative.

Primary outcome measures

  • •Magnetic resonance imaging of the brain (MRI) with contrast. [Time frame: 2 weeks]
  • Optic nerve sheath diameter for assessment of intracranial tension. [Time frame: 2 weeks]
Secondary outcome measures (2)
  • Tumor necrosis factor alpha (TNF-α). [Time frame: 2 weeks]
  • Interlukin-6 (IL-6). [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

  • Males \& females.
  • Age: between 18 and 75 years old.
  • Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by:
  • The initial clinical examination.
  • Magnetic resonance imaging of the brain (MRI) with contrast.

Exclusion criteria

  • Age: > 75 years old, and <18 years old.
  • Breast feeding female. • Pregnant female.
  • eGFR< 30 mL/minute/1.73 m2.
  • Patients with diabetes mellitus.
  • Patients with diabetic ketoacidosis.
  • Patients with urinary tract infection.
  • Dehydrated patients till normalized.
  • Lower limb amputation patients.
  • SGLT2 inhibitors hypersensitivity.
  • Severe hepatic patients (child-plug score class-c).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Takashima M, Nakamura K, Kiyohara T, Wakisaka Y, Hidaka M, Takaki H, Yamanaka K, Shibahara T, Wakisaka M, Ago T, Kitazono T. Low-dose sodium-glucose cotransporter 2 inhibitor ameliorates ischemic brain injury in mice through pericyte protection without glucose-lowering effects. Commun Biol. 2022 Jul 2;5(1):653. doi: 10.1038/s42003-022-03605-4. PMID 35780235
  • Shim B, Stokum JA, Moyer M, Tsymbalyuk N, Tsymbalyuk O, Keledjian K, Ivanova S, Tosun C, Gerzanich V, Simard JM. Canagliflozin, an Inhibitor of the Na+-Coupled D-Glucose Cotransporter, SGLT2, Inhibits Astrocyte Swelling and Brain Swelling in Cerebral Ischemia. Cells. 2023 Sep 6;12(18):2221. doi: 10.3390/cells12182221. PMID 37759444
  • Saeedi S, Rezayi S, Keshavarz H, R Niakan Kalhori S. MRI-based brain tumor detection using convolutional deep learning methods and chosen machine learning techniques. BMC Med Inform Decis Mak. 2023 Jan 23;23(1):16. doi: 10.1186/s12911-023-02114-6. PMID 36691030
  • Weller M, Wen PY, Chang SM, Dirven L, Lim M, Monje M, Reifenberger G. Glioma. Nat Rev Dis Primers. 2024 May 9;10(1):33. doi: 10.1038/s41572-024-00516-y. PMID 38724526

Identifiers

NCT: NCT06750458 · 36265MD324/12/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗