Back to resultsCytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
Primary Purpose
Diffuse Traumatic Cerebral Edema
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Progesteron
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Traumatic Cerebral Edema focused on measuring Progesterone, brain tumor, Neuronal biopsy
Eligibility Criteria
Inclusion Criteria:
- All elective brain tumors elligible for craniotomy
Exclusion Criteria:
- Refusal to participare
- Emergency craniotomy
Sites / Locations
- Faculty of MedicineRecruiting
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
progesterone group
Arm Description
Control group receiving conventional treatment without progesterone
1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface
Outcomes
Primary Outcome Measures
Number of Participants With craniotomy-Related Adverse Events
Degree of microscopic cellular injury and brain odema in brain biopsy
Secondary Outcome Measures
Number of Participants with neuronal deficit
Sensory, motor or autonomic dysfunction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04414020
Brief Title
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
Official Title
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty
Detailed Description
Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Traumatic Cerebral Edema
Keywords
Progesterone, brain tumor, Neuronal biopsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group receiving conventional treatment without progesterone
Arm Title
progesterone group
Arm Type
Active Comparator
Arm Description
1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface
Intervention Type
Drug
Intervention Name(s)
Progesteron
Intervention Description
intramusculer progesterone
Primary Outcome Measure Information:
Title
Number of Participants With craniotomy-Related Adverse Events
Description
Degree of microscopic cellular injury and brain odema in brain biopsy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants with neuronal deficit
Description
Sensory, motor or autonomic dysfunction
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All elective brain tumors elligible for craniotomy
Exclusion Criteria:
Refusal to participare
Emergency craniotomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina Raouf, MD
Phone
01015752424
Email
drmina2015@gmail.com
Facility Information:
Facility Name
Faculty of Medicine
City
Al Minyā
State/Province
Abohelal
ZIP/Postal Code
6115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mina raouf, MD
Phone
01015752424
Email
Drmina2015@gmail.com
First Name & Middle Initial & Last Name & Degree
omaima mohammad, MD
Phone
01061762894
Email
Omayamshehata@yahoo.com
Facility Name
Faculty of Medicine
City
Minya
State/Province
Abohelal
ZIP/Postal Code
6115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mina raouf, MD
Phone
01015752424
Email
Drmina2015@gmail.com
First Name & Middle Initial & Last Name & Degree
omaima mohammad, MD
Phone
01061762894
Email
Omayamshehata@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
We'll reach out to this number within 24 hrs