Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

Last updated: January 13, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Carcinoid Syndrome And Carcinoid Tumours

Digestive System Neoplasms

Brain Tumor

Treatment

Placebo

Hormone replacement therapy

Clinical Study ID

NCT06679816
HEALTH
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1) Age range: 18-70 years old;

  • (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidalsurgery;

  • (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

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 Design

Total Participants: 882
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
December 04, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Beijing, Beijing Tiantan Hospital,Capital Medical University

    Beijing, Beijing 100070
    China

    Active - Recruiting

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