ACTIVE_NOT_RECRUITING

Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

Conditions

Autonomous Cortisol Secretion Mild Autonomous Cortisol Secretion (MACS)Hypercortisolism Cortisol excess Cushing syndrome Adrenal adenoma Adrenal hyperplasia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether the study drug, metyrapone, is safe and effective in treating participants with Mild Autonomous Cortisol Secretion (MACS).

Official Title

Metyrapone Intervention in Patients With Mild Autonomous Cortisol Secretion (MACS)

Quick Facts

Study Start:2023-12-19

Study Completion:2028-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06106295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provide written informed consent. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Diagnosed with MACS: at least 2 abnormal post-dexamethasone cortisol results (1 mg post-dexamethasone cortisol \> 1.8 mcg/d; or 8 mg post-dexamethasone cortisol \> 1 mcg/dL) and historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment. * Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia). * At least one of the following comorbidities: obesity (BMI \> 30 kg/m\^2); dysglycemia; dyslipidemia; hypertension; osteopenia; osteoporosis; fragility fractures. * Ability to take oral medication and be willing to adhere to the study intervention regimen. * For females of reproductive potential: use of highly effective contraception initiated prior to baseline visit and for 1 month after completing metyrapone study. * For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \<5% per year during the treatment period and for 6 months after the last dose of study treatment. * Stable timing for bedtime for at least one week prior to on-site study visits	* Planned alternative therapy for MACS within 6 months after joining the study. * Current use of oral exogenous glucocorticoid therapy. * Current use of opioid therapy \> 20 MME/day. * Planned use of oral exogenous glucocorticoid therapy. * Planned use of opioid therapy \> 20 MME/day. * Use of injectable glucocorticoid within the last 6 weeks. * Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements. * Pregnancy or lactation. * Known allergic reactions to metyrapone. * Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone. * Treatment with another investigational drug or other intervention within lower than specific therapy washout period.

Inclusion Criteria

Exclusion Criteria

* Provide written informed consent.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Diagnosed with MACS: at least 2 abnormal post-dexamethasone cortisol results (1 mg post-dexamethasone cortisol \> 1.8 mcg/d; or 8 mg post-dexamethasone cortisol \> 1 mcg/dL) and historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment.
* Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia).
* At least one of the following comorbidities: obesity (BMI \> 30 kg/m\^2); dysglycemia; dyslipidemia; hypertension; osteopenia; osteoporosis; fragility fractures.
* Ability to take oral medication and be willing to adhere to the study intervention regimen.
* For females of reproductive potential: use of highly effective contraception initiated prior to baseline visit and for 1 month after completing metyrapone study.
* For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \<5% per year during the treatment period and for 6 months after the last dose of study treatment.
* Stable timing for bedtime for at least one week prior to on-site study visits

* Planned alternative therapy for MACS within 6 months after joining the study.
* Current use of oral exogenous glucocorticoid therapy.
* Current use of opioid therapy \> 20 MME/day.
* Planned use of oral exogenous glucocorticoid therapy.
* Planned use of opioid therapy \> 20 MME/day.
* Use of injectable glucocorticoid within the last 6 weeks.
* Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnancy or lactation.
* Known allergic reactions to metyrapone.
* Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone.
* Treatment with another investigational drug or other intervention within lower than specific therapy washout period.

Contacts and Locations

Principal Investigator

Irina Bancos, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Irina Bancos, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19

Study Completion Date2028-02-01

Study Record Updates

Study Start Date2023-12-19

Study Completion Date2028-02-01

Terms related to this study

Keywords Provided by Researchers

Hypercortisolism
Cortisol excess
Cushing syndrome
Adrenal adenoma
Adrenal hyperplasia

Additional Relevant MeSH Terms

Autonomous Cortisol Secretion
Mild Autonomous Cortisol Secretion (MACS)