About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks,
inability to provide informed consent
Trial population
Any male or female at least 18 years of age undergoing curative surgery for Cushing's Syndrome and MACS.
Trial design
Cohort
Prospective
Treatments tested in this trial
MUSE biofeedback
Other interventionbiofeedback through a headband
Treatment groups
Trial outcomes
Primary outcomes
Quality of life (SF36)
Score 0-100
Secondary outcomes
HPA recovery
as measured by morning cortisol. Cortisol measurement will be performes every 6-12 weeks, 24h off glucocorticoid replacement therapy starting 4 weeks-8 weeks after surgery and until cortisol is 10 mcg/dl or above ( or HPA recovery is considered impossible by investigator)
Myopathy measurement
as measured by hand grip. Hand grip strength will be measured 3 times on left and right, and dominant hand grip strength will be considered as an average of 3 measurements.
Other outcomes
AGE
measurement of AGE
Sponsors and contacts
Click on the lead sponsor to view all of their trials.