Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

NCT06679816 | Recruiting Phase 4

• 1 other identifier: HEALTH
• Study Type: interventional
• Target: 882
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pituitary Adenoma; Pituitary Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• The incidence of adrenal insufficiency on the first or second day after surgery

  the first or second day after surgery

Secondary Outcomes (1)

• The incidence of adrenal insufficiency within 90 days after surgery

  Within 90 days after surgery

Study Arms (2)

Hormone supplementation therapy group

EXPERIMENTAL

Drug: Hormone replacement therapy

Placebo therapy group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hormone replacement therapy DRUG

Perioperative Hydrocortisone Reduction Therapy

Hormone supplementation therapy group

Placebo DRUG

Perioperative placebo Reduction Therapy

Placebo therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing, Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

xingchao wang, Phd

CONTACT

15101053127; wangxc@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: December 4, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

CN (1)