Health TrialsbyHealthPanel

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

ConditionsGliomaDapagliflozin (Forxiga)Dexamethasone
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males & females.

Age: between 18 and 75 years old.

The initial clinical examination.

Magnetic resonance imaging of the brain (MRI) with contrast.

Disqualifiers

Age: > 75 years old, and <18 years old.

Breast feeding female. • Pregnant female.

eGFR< 30 mL/minute/1.73 m2.

Patients with diabetes mellitus.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin placebo

    Drug

    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

  • Placebo

    Drug

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

  • DexamethasoneGroup III (n=25) (Dexamethasone group)

    Drug

    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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: GroupⅠ(n=25) (Control group)Placebo comparator 1 intervention
Group B: GroupII (n=25) (Dapagliflozin group)Experimental treatment 1 intervention
Group C: Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patienActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

•Magnetic resonance imaging of the brain (MRI) with contrast.

Time frame
2 weeks
2

Optic nerve sheath diameter for assessment of intracranial tension.

Time frame
2 weeks

Secondary outcomes

1

Tumor necrosis factor alpha (TNF-α).

Time frame
2 weeks
2

Interlukin-6 (IL-6).

Time frame
2 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: