Adrenal Insufficiency Clinical Trial
Official title:
Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients
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.
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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