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Hormone Therapy

Progesterone for Glioblastoma

Q: What afflictions are usually addressed by Quality-of-Life Assessment?

Quality-of-Life Assessments are typically prescribed to prevent preterm birth. Other illnesses that can be treated with this medication include adenocarcinoma and premature labour.

Q: Are new participants being accepted into the trial at this time?

According to the clinicaltrials.gov records, this research project is actively seeking participants and was originally posted on April 11th 2022 before being revised that same day.

Q: What evidence has been collected pertaining to Quality-of-Life Assessment?

At present, 43 clinical studies are in progress investigating Quality-of-Life Assessment. Of those trials, 8 have reached Phase 3 development and the majority of these experiments are based out of Barcelona, Catalunya with a total 269 sites hosting relevant research.

Q: What is the upper bound of participants for this experiment?

Yes, clinicaltrials.gov shows that this research is actively seeking patients to participate in the study. The trial's inception was on April 11th 2022 and its status has been most recently updated on the same day. 32 participants are required from a single site for completion of the experiment.

Phase < 1

Recruiting

Led By Hui-Kuo G Shu

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy

Recurrent GBM must consist of a minimum of 1 cm^3 of contrast enhancing disease on high resolution T1 post-contrast sequence as defined on pre-treatment MRI obtained within 14 days of initiating therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the effects of progesterone on recurrent glioblastoma. Progesterone is a hormone that the body uses in the menstrual cycle and pregnancy. It may help control tumor growth.

Who is the study for?

This trial is for adults with recurrent glioblastoma who can undergo MRI scans, have certain blood cell counts within normal ranges, and a life expectancy of at least 12 weeks. Women must not be pregnant and agree to use contraception. Excluded are those with active infections, recent thromboembolic disease, incompatible implants for MRI, severe liver issues, history of breast or genital cancers (unless in remission for 3+ years), or on other anti-tumor therapies.Check my eligibility

What is being tested?

The trial is testing natural progesterone's effectiveness in controlling tumor growth in patients with recurrent glioblastoma. It involves determining the best dose and observing potential benefits or side effects while monitoring quality-of-life through assessments and questionnaires.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to progesterone, changes related to hormone levels such as mood swings or weight gain, digestive disturbances like nausea or bloating, and possibly increased risk of blood clots due to hormonal influence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently participating in another cancer treatment trial.

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My brain tumor is at least 1 cm^3 in size on my recent MRI.

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My diagnosis of glioblastoma or gliosarcoma was confirmed through surgery.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

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I am not pregnant and agree to use birth control or abstain from sex during the study.

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I am not experiencing any active vaginal bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Natural progesterone blood levels

Overall response rate

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

Other outcome measures

C-Reactive Protein

EORTC Quality-of-life (QOL) Questionnaire Core 30/Brain Cancer Module-20

Gilal Fibrillary Acidic Protein

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (progesterone)Experimental Treatment3 Interventions

Patients receive progesterone SC QD for up to 24 weeks in the absence of disease progression or unacceptable toxicity.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,664 Total Patients Enrolled

11 Trials studying Glioblastoma

316 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,822 Total Patients Enrolled

322 Trials studying Glioblastoma

23,083 Patients Enrolled for Glioblastoma

Hui-Kuo G ShuPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Therapeutic Progesterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05091866 — Phase < 1

Glioblastoma Research Study Groups: Treatment (progesterone)

Glioblastoma Clinical Trial 2023: Therapeutic Progesterone Highlights & Side Effects. Trial Name: NCT05091866 — Phase < 1

Therapeutic Progesterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091866 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What afflictions are usually addressed by Quality-of-Life Assessment?

"Quality-of-Life Assessments are typically prescribed to prevent preterm birth. Other illnesses that can be treated with this medication include adenocarcinoma and premature labour."

Answered by AI

Are new participants being accepted into the trial at this time?

"According to the clinicaltrials.gov records, this research project is actively seeking participants and was originally posted on April 11th 2022 before being revised that same day."

Answered by AI

What evidence has been collected pertaining to Quality-of-Life Assessment?

"At present, 43 clinical studies are in progress investigating Quality-of-Life Assessment. Of those trials, 8 have reached Phase 3 development and the majority of these experiments are based out of Barcelona, Catalunya with a total 269 sites hosting relevant research."

Answered by AI

What is the upper bound of participants for this experiment?

"Yes, clinicaltrials.gov shows that this research is actively seeking patients to participate in the study. The trial's inception was on April 11th 2022 and its status has been most recently updated on the same day. 32 participants are required from a single site for completion of the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Natural Progesterone for the Treatment of Recurrent Glioblastoma

Hui-Kuo Shu 2022. "Natural Progesterone for the Treatment of Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05091866.