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Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients

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ClinicalTrials.gov Identifier: NCT03083834
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
leonard.saiegh, Bnai Zion Medical Center

Brief Summary:

In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases cortisol binding globulin levels (CBG), artificially raising total cortisol. Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the free serum cortisol.

In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.


Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Adrenal Cancer Diagnostic Test: Cosyntropin stimulation test Not Applicable

Detailed Description:

80-90% of circulating cortisol is bound to cortisol binding globulin (CBG) or transcortin, whereas only 3-10% is in the free state. Salivary free cortisol (SC) is an index of plasma free cortisol. In previous studies it was shown that in low-dose cosyntropin stimulation test, SC increases significantly in normal but not in hypoadrenal patients. It was suggested that dynamic assessment of the SC response to ACTH may be particularly helpful whenever the measurement of serum cortisol is complicated by increased or decreased CBG levels.

Adrenocortical carcinoma (ACC) is a rare malignancy with a heterogeneous presentation and a variable but generally poor prognosis. Mitotane is the main drug for ACC treatment and it plays a role both in adjuvant treatment after complete resection and in recurrent, inoperable and/or metastatic ACC. Mitotane blocks adrenocortical steroid synthesis and also exerts a specific cytotoxic effect on adrenocortical cells. Mitotane induces adrenal insufficiency, requiring hydrocortisone replacement therapy. In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases CBG levels, artificially raising total cortisol. SC is not affected by CBG alterations, and reflects the free serum cortisol and may be more accurate in diagnosing hypoadrenalism in mitotane treated patients.

In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from any other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: healthy subjects
low-dose cosyntropin stimulation test
Diagnostic Test: Cosyntropin stimulation test
At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein. Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.

Experimental: hypoadrenal mitotane treated patients
low-dose cosyntropin stimulation test
Diagnostic Test: Cosyntropin stimulation test
At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein. Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.

Experimental: hypoadrenal no-mitotane treated patients
low-dose cosyntropin stimulation test
Diagnostic Test: Cosyntropin stimulation test
At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein. Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.




Primary Outcome Measures :
  1. Salivary free cortisol [ Time Frame: 1 day ]
    Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation test..


Secondary Outcome Measures :
  1. serum cortisol [ Time Frame: 1 day ]
    Serum cortisol concentrations during intravenous low dose cosyntropin stimulation test.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mitotane treated
  • known hypoadrenlism

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083834


Contacts
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Contact: Leonard Saiegh, MD +972506267262 leonard.saiegh@gmail.com

Locations
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Israel
Bnai Zion MC Recruiting
Haifa, Israel
Contact: Leonard Saiegh    506267262    leonard.saiegh@gmail.com   
Contact: Michal Yeiches    0528283062    yeiches@gmail.com   
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Principal Investigator: Leonard Saiegh, MD Bnai Zion Medical Center

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Responsible Party: leonard.saiegh, MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT03083834     History of Changes
Other Study ID Numbers: 0006-17-BNZ
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by leonard.saiegh, Bnai Zion Medical Center:
cosyntropin
salivary free cortisol
mitotane

Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cosyntropin
Mitotane
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents