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

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: Glioma; Dapagliflozin (Forxiga); Dexamethasone

Treatments: Drug: DexamethasoneGroup III (n=25) (Dexamethasone group); Drug: Dapagliflozin placebo; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06750458

36265MD324/12/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

GroupⅠ(n=25) (Control group)

Placebo Comparator group

Description:

This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive placebo tablets once daily for 14 days pre-operative.

Treatment:

Drug: Placebo

GroupII (n=25) (Dapagliflozin group)

Experimental group

Description:

This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dapagliflozin 10 mg once daily for 14 days pre-operative.

Treatment:

Drug: Dapagliflozin placebo

Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien

Active Comparator group

Description:

This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative.

Treatment:

Drug: DexamethasoneGroup III (n=25) (Dexamethasone group)