RECRUITING

Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cushing syndrome (CS) is an endocrine disorder caused by chronic exposure to glucocorticoid (GC) excess. Endogenous CS has an estimated incidence of 0.2 to 5.0 cases per million per year and prevalence of 39 to 79 cases per million in various populations. CS usually affects young women, with a median age at diagnosis of 41.4 with a female-to-male ratio of 3:1. Following a curative surgery for CS, patients develop adrenal insufficiency and require GC replacement postoperatively until the hypothalamic-pituitary-adrenal (HPA) axis recovery occurs. Factors, such as age, gender, BMI, subtypes of CS, duration of symptoms, clinical and biochemical severity and postoperative GC dose have been reported to affect the HPA recovery in small retrospective studies. Glucocorticoid withdrawal syndrome (GWS) is a withdrawal reaction due to decrease in supraphysiological GC concentrations, which occurs after a successful surgery of CS. Glucocorticoid withdrawal syndrome (GWS) is under-recognized entity in patients undergoing curative surgery for endogenous Cushing syndrome. In this study we aim to determine pre- and post-surgical predictors of the duration and severity of glucocorticoid withdrawal in patients undergoing a curative surgery for cortisol excess and assess the effect of MUSE intervention on GWS severity in patients undergoing curative surgery for CS as compared to standard of care.

Official Title

Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)

Quick Facts

Study Start:2019-07-25
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04543253

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age 18 and above,
  2. 2. new diagnosis of CS of any of the three subtypes (pituitary, adrenal or ectopic CS), and MACS,
  3. 3. planning for a curative surgery
  4. 4. ability to provide informed consent.
  1. 1. systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks,
  2. 2. inability to provide informed consent

Contacts and Locations

Study Contact

Melinda Thomas
CONTACT
507-293-6628
thomas.melinda@mayo.edu

Principal Investigator

Irina Bancos, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Irina Bancos, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Registration Dates

Study Start Date2019-07-25
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-07-25
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Hypercortisolism
  • Cushing syndrome
  • Cushing disease
  • Pituitary

Additional Relevant MeSH Terms

  • Cushing Syndrome