Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

May 30, 2020 updated by: Mina Maher, Minia University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Abohelal
      • Al Minyā, Abohelal, Egypt, 6115
      • Minya, Abohelal, Egypt, 6115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All elective brain tumors elligible for craniotomy

Exclusion Criteria:

  • Refusal to participare
  • Emergency craniotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group receiving conventional treatment without progesterone
Active Comparator: progesterone group
1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface
Drug: Progesteron
intramusculer progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With craniotomy-Related Adverse Events
Time Frame: 3 months
Degree of microscopic cellular injury and brain odema in brain biopsy
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with neuronal deficit
Time Frame: 2 months
Sensory, motor or autonomic dysfunction
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 623-4/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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