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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04543253
Status
Recruiting
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Conditions

  • Cushing Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MUSE biofeedback — OTHER
    biofeedback through a headband

Study Details

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.

Key Dates

Start date
Jul 25, 2019
Status verified
Aug 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: Standard of care CS
    Patients undergoing curative surgery for any type of CS who will be followed through standard of care after surgery
  • Arm: MUSE intervention CS
    Patients undergoing curative surgery for any type of CS who will be introduced to and provided MUSE for use after surgery

Primary Outcome Measure

Quality of life (SF36) [ Time Frame: periodic 0-24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Melinda Thomas
[email protected]
507-293-6628
Irina Bancos, MD (PRINCIPAL_INVESTIGATOR)

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