Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04543253
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2020-04-10
Brief Title:
Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion MACS
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion MACS
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cushing syndrome CS is an endocrine disorder caused by chronic exposure to glucocorticoid GC excess Endogenous CS has an estimated incidence of 02 to 50 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 414 with a female-to-male ratio of 31 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
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
Detailed Description:
Specific Aim 1 To determine pre- and post-surgical predictors of the duration and severity of glucocorticoid withdrawal in patients undergoing a curative surgery for cortisol excess Specific Aim 2 To characterize the timing and recovery of hypercortisolism-induced signs and symptoms proximal myopathy and tissue accumulation of Advanced Glycation End products AGEs in patients after a curative surgery Specific Aim 3 To assess the effect of MUSE intervention on GWS severity in patients undergoing curative surgery for CS as compared to standard of care
1 Selection of study subjects and medical records review We will prospectively recruit adult patients with CS of any three subtypes pituitary adrenal or ectopic CS and MACS undergoing a curative surgery from the pituitary clinic Investigator will discuss participation in the study and obtain an informed consent We will review data for any potential risk factors through clinical interview and review of medical record Data will include demographics behavioral factors smoking and alcohol consumption past medical history history of AI psychiatric disorder and recent GC usage GWS related symptoms and signs anorexia nausea emesis lethargy somnolence arthralgia myalgia fever hypotension and lab tests
2 Subjects We will enroll 100 consecutive subjects in this study who will participate in this study for up to 2 years Inclusion and exclusion criteria are as below We plan to have 50 subjects participate in the intervention arm with MUSE in one year without modifying other study procedures
3 Step-by-Step methods
Patients will be identified by their clinician Permission will be obtained from the patient in order for one of the investigators to explain the study and obtain informed written consent
Baseline history physical examination and the necessary baseline tests will be performed based on standard of care and as considered necessary by the treating physician
Medical record will be reviewed for demographic information comorbidities medical therapy imaging information and biochemical testing results
We will use a scoring system to quantify biochemical severity and to classify clinical abnormalities as mild moderate and severe based on existent laboratory and clinical parameters
At baseline all patients will be asked to complete the Cushing QoL questionnaire SF36 and AddiQol questionnaires forms are attached in Document Patients will discuss the intervention with MUSE with the study investigator If they agree to participate in the intervention arm they will be instructed on its use
At follow up patients will complete AddQoL survey weekly in the first 3 months every 4 weeks in the next 6 months every 3 months in the next 12 months and then every 6 months until the end of the study and SF36 survey every 3 months until the end of the study In-person through a paper survey or electronically using external REDCap server user name and password protected
For patients in the intervention group in addition to the above at the time of enrollment the study coordinator will help set up the MUSE application on to iPad or iPhone or Android phone we will use generic login name and password without protected health information included The coordinator will also go over a few helpful hints and discuss the homework log which will need to be completed throughout the course of the study After the surgery patients are asked to complete the 3 minute focusing exercise daily until 12 weeks after the surgery During this time frame we will download the data from our end on a weekly basis After 12 weeks the frequency of the usage will be at the participants discretion although ongoing usage is encouraged and data download should continue In addition we ask that patients bring iPad iPhone or Android phone to each of the clinical visit for an app interrogation
Patient will participate in the study until one of the following 1 2 years of follow up completed 2 patient withdraws consent 3 HPA axis recovery is achieved and patient weans off GC 4 completion of the study by the principal investigator
1 Selection of study subjects and medical records review We will prospectively recruit adult patients with CS of any three subtypes pituitary adrenal or ectopic CS and MACS undergoing a curative surgery from the pituitary clinic Investigator will discuss participation in the study and obtain an informed consent We will review data for any potential risk factors through clinical interview and review of medical record Data will include demographics behavioral factors smoking and alcohol consumption past medical history history of AI psychiatric disorder and recent GC usage GWS related symptoms and signs anorexia nausea emesis lethargy somnolence arthralgia myalgia fever hypotension and lab tests
2 Subjects We will enroll 100 consecutive subjects in this study who will participate in this study for up to 2 years Inclusion and exclusion criteria are as below We plan to have 50 subjects participate in the intervention arm with MUSE in one year without modifying other study procedures
3 Step-by-Step methods
Patients will be identified by their clinician Permission will be obtained from the patient in order for one of the investigators to explain the study and obtain informed written consent
Baseline history physical examination and the necessary baseline tests will be performed based on standard of care and as considered necessary by the treating physician
Medical record will be reviewed for demographic information comorbidities medical therapy imaging information and biochemical testing results
We will use a scoring system to quantify biochemical severity and to classify clinical abnormalities as mild moderate and severe based on existent laboratory and clinical parameters
At baseline all patients will be asked to complete the Cushing QoL questionnaire SF36 and AddiQol questionnaires forms are attached in Document Patients will discuss the intervention with MUSE with the study investigator If they agree to participate in the intervention arm they will be instructed on its use
At follow up patients will complete AddQoL survey weekly in the first 3 months every 4 weeks in the next 6 months every 3 months in the next 12 months and then every 6 months until the end of the study and SF36 survey every 3 months until the end of the study In-person through a paper survey or electronically using external REDCap server user name and password protected
For patients in the intervention group in addition to the above at the time of enrollment the study coordinator will help set up the MUSE application on to iPad or iPhone or Android phone we will use generic login name and password without protected health information included The coordinator will also go over a few helpful hints and discuss the homework log which will need to be completed throughout the course of the study After the surgery patients are asked to complete the 3 minute focusing exercise daily until 12 weeks after the surgery During this time frame we will download the data from our end on a weekly basis After 12 weeks the frequency of the usage will be at the participants discretion although ongoing usage is encouraged and data download should continue In addition we ask that patients bring iPad iPhone or Android phone to each of the clinical visit for an app interrogation
Patient will participate in the study until one of the following 1 2 years of follow up completed 2 patient withdraws consent 3 HPA axis recovery is achieved and patient weans off GC 4 completion of the study by the principal investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None