Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

January 13, 2025 updated by: Beijing Tiantan Hospital

Study on the Efficacy of Hydrocortisone in Perioperative Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors:a Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled Study

The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are:

• Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency.

Participants will:

  • Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks
  • Visit the clinic three months after surgery for checkups and tests
  • Keep a diary of their symptoms

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

882

Phase

  • Phase 4

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing, Beijing Tiantan Hospital,Capital Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Age range: 18-70 years old;
  • (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
  • (3) The maximum diameter of the tumor is ≥ 2 centimeters;
  • (4) Preoperative hypothalamic pituitary adrenal axis integrity;
  • (5) The subject or their legal representative signs the informed consent form

Exclusion Criteria:

  • (1) Patients with a history of Cushing's disease or adrenal insufficiency;
  • (2) Emergency and combined hormone therapy patients;
  • (3) Pituitary stroke patients;
  • (4) Patients lacking head magnetic resonance imaging;

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hormone supplementation therapy group
Drug: Hormone replacement therapy
Perioperative Hydrocortisone Reduction Therapy
Placebo Comparator: Placebo therapy group
Drug: Placebo
Perioperative placebo Reduction Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of adrenal insufficiency on the first or second day after surgery
Time Frame: the first or second day after surgery
the first or second day after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of adrenal insufficiency within 90 days after surgery
Time Frame: Within 90 days after surgery
Within 90 days after surgery

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

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 (Actual)

December 4, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEALTH (samsun provincial health directorate)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Research data involves subject privacy

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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