NCT04543253

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2019Dec 2030

Study Start

First participant enrolled

July 25, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

11.4 years

First QC Date

April 10, 2020

Last Update Submit

August 26, 2025

Conditions

Cushing Syndrome

Keywords

HypercortisolismCushing syndromeCushing diseasePituitary

Outcome Measures

Primary Outcomes (1)

  • Quality of life (SF36)

    Score 0-100

    periodic 0-24 months

Secondary Outcomes (2)

  • HPA recovery

    0-24 months

  • Myopathy measurement

    0-24 months

Other Outcomes (1)

  • AGE

    0-24 months

Study Arms (2)

Standard of care CS

Patients undergoing curative surgery for any type of CS who will be followed through standard of care after surgery

MUSE intervention CS

Patients undergoing curative surgery for any type of CS who will be introduced to and provided MUSE for use after surgery

Other: MUSE biofeedback

Interventions

MUSE biofeedbackOTHER

biofeedback through a headband

MUSE intervention CS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any male or female at least 18 years of age undergoing curative surgery for Cushing's Syndrome and MACS.

You may qualify if:

  • age 18 and above,
  • new diagnosis of CS of any of the three subtypes (pituitary, adrenal or ectopic CS), and MACS,
  • planning for a curative surgery
  • ability to provide informed consent.

You may not qualify if:

  • systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks,
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Cushing SyndromePituitary ACTH HypersecretionPituitary Diseases

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHyperpituitarismHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Irina Bancos, MD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Fell, MA

CONTACT

507-266-6068fell.vanessa@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2020

First Posted

September 10, 2020

Study Start

July 25, 2019

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)