Understanding recovery from Cushing syndrome after surgery
Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)
Mayo Clinic · NCT04543253
This study looks at how people with Cushing syndrome recover after surgery and whether a special biofeedback program can help with symptoms after stopping steroid treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04543253 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the recovery process in patients with Cushing syndrome (CS) following curative surgery. It will assess pre- and post-surgical factors that influence the duration and severity of glucocorticoid withdrawal syndrome (GWS) and characterize the recovery of symptoms related to hypercortisolism. The study will involve the recruitment of 100 adult patients diagnosed with CS of various subtypes, who will be monitored for up to two years. Additionally, the impact of a MUSE biofeedback intervention on GWS severity will be evaluated compared to standard care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above with a new diagnosis of Cushing syndrome planning for curative surgery.
Not a fit: Patients who have received systemic supraphysiological glucocorticoids within one month prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and recovery outcomes for patients undergoing surgery for Cushing syndrome.
How similar studies have performed: While there have been small retrospective studies on recovery from Cushing syndrome, this study's specific approach to assessing GWS and recovery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18 and above, 2. new diagnosis of CS of any of the three subtypes (pituitary, adrenal or ectopic CS), and MACS, 3. planning for a curative surgery 4. ability to provide informed consent. Exclusion Criteria: 1. systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks, 2. inability to provide informed consent
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Irina Bancos, MD, MS — Mayo Clinic
- Study coordinator: Vanessa Fell, MA
- Email: fell.vanessa@mayo.edu
- Phone: 507-266-6068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cushing Syndrome, Hypercortisolism, Cushing syndrome, Cushing disease, Pituitary