The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma
NCT ID: NCT05344027
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2022-04-11
2023-03-01
Brief Summary
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Detailed Description
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Aims: Evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare to patients with an adrenal neoplasm and a pregnant cohort. Patients were treated at King's Hospital between April 2019 and June 2020.
Methods: Cortisol, TFT's ACTH, CBG, TBG and gonadotrophins will be measured during the same venepuncture using serum samples. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Thirty-five patients will be included, within ACC with mitotane, adrenal neoplasm or pregnant groups. Data will be tested for normality, described as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ACC on mitotane
Individuals in this group were under care by the Endocrinology Team with a diagnosis of an ACC and on mitotane. These individuals were further divided into 3 groups, depending on whether they had a mitotane plasma concentration, within (14-20mg/L), above or below the therapeutic concentration range.
Mitotane
Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.
Adrenal neoplasm without mitotane
Individuals within this category had an adrenal neoplasm and were not being treated with mitotane therapy.
No interventions assigned to this group
Pregnant group
Individuals did not have an adrenal neoplasm during this period, nor were they being treated with mitotane. These were healthy pregnant females, who were under the care at KCL during their pregnancy.
No interventions assigned to this group
Interventions
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Mitotane
Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
19 Years
85 Years
ALL
Yes
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Kerkhofs TM, Verhoeven RH, Van der Zwan JM, Dieleman J, Kerstens MN, Links TP, Van de Poll-Franse LV, Haak HR. Adrenocortical carcinoma: a population-based study on incidence and survival in the Netherlands since 1993. Eur J Cancer. 2013 Jul;49(11):2579-86. doi: 10.1016/j.ejca.2013.02.034. Epub 2013 Apr 3.
Scollo C, Russo M, Trovato MA, Sambataro D, Giuffrida D, Manusia M, Sapuppo G, Malandrino P, Vigneri R, Pellegriti G. Prognostic Factors for Adrenocortical Carcinoma Outcomes. Front Endocrinol (Lausanne). 2016 Jul 25;7:99. doi: 10.3389/fendo.2016.00099. eCollection 2016.
Alexandraki KI, Kaltsas GA, le Roux CW, Fassnacht M, Ajodha S, Christ-Crain M, Akker SA, Drake WM, Edwards R, Allolio B, Grossman AB. Assessment of serum-free cortisol levels in patients with adrenocortical carcinoma treated with mitotane: a pilot study. Clin Endocrinol (Oxf). 2010 Mar;72(3):305-11. doi: 10.1111/j.1365-2265.2009.03631.x. Epub 2009 May 16.
Russo M, Scollo C, Pellegriti G, Cotta OR, Squatrito S, Frasca F, Cannavo S, Gullo D. Mitotane treatment in patients with adrenocortical cancer causes central hypothyroidism. Clin Endocrinol (Oxf). 2016 Apr;84(4):614-9. doi: 10.1111/cen.12868. Epub 2015 Aug 18.
Fassnacht M, Allolio B. Clinical management of adrenocortical carcinoma. Best Pract Res Clin Endocrinol Metab. 2009 Apr;23(2):273-89. doi: 10.1016/j.beem.2008.10.008.
Allolio B, Fassnacht M. Clinical review: Adrenocortical carcinoma: clinical update. J Clin Endocrinol Metab. 2006 Jun;91(6):2027-37. doi: 10.1210/jc.2005-2639. Epub 2006 Mar 21.
van Erp NP, Guchelaar HJ, Ploeger BA, Romijn JA, Hartigh Jd, Gelderblom H. Mitotane has a strong and a durable inducing effect on CYP3A4 activity. Eur J Endocrinol. 2011 Apr;164(4):621-6. doi: 10.1530/EJE-10-0956. Epub 2011 Jan 10.
Fassnacht M, Assie G, Baudin E, Eisenhofer G, de la Fouchardiere C, Haak HR, de Krijger R, Porpiglia F, Terzolo M, Berruti A; ESMO Guidelines Committee. Electronic address: [email protected]. Adrenocortical carcinomas and malignant phaeochromocytomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Nov;31(11):1476-1490. doi: 10.1016/j.annonc.2020.08.2099. Epub 2020 Aug 27. No abstract available.
Sada A, Glasgow AE, Lyden ML, Dy BM, Foster TR, Habermann EB, Bancos I, McKenzie TJ. Informing therapeutic lymphadenectomy: Location of regional metastatic lymph nodes in adrenocortical carcinoma. Am J Surg. 2022 Jun;223(6):1042-1045. doi: 10.1016/j.amjsurg.2021.10.014. Epub 2021 Oct 19.
Lehmann TP, Wrzesinski T, Jagodzinski PP. The effect of mitotane on viability, steroidogenesis and gene expression in NCI-H295R adrenocortical cells. Mol Med Rep. 2013 Mar;7(3):893-900. doi: 10.3892/mmr.2012.1244. Epub 2012 Dec 18.
Tran TB, Liou D, Menon VG, Nissen NN. Surgical management of advanced adrenocortical carcinoma: a 21-year population-based analysis. Am Surg. 2013 Oct;79(10):1115-8.
van Seters AP, Moolenaar AJ. Mitotane increases the blood levels of hormone-binding proteins. Acta Endocrinol (Copenh). 1991 May;124(5):526-33. doi: 10.1530/acta.0.1240526.
Daffara F, De Francia S, Reimondo G, Zaggia B, Aroasio E, Porpiglia F, Volante M, Termine A, Di Carlo F, Dogliotti L, Angeli A, Berruti A, Terzolo M. Prospective evaluation of mitotane toxicity in adrenocortical cancer patients treated adjuvantly. Endocr Relat Cancer. 2008 Dec;15(4):1043-53. doi: 10.1677/ERC-08-0103. Epub 2008 Sep 29.
Fassnacht M, Dekkers OM, Else T, Baudin E, Berruti A, de Krijger R, Haak HR, Mihai R, Assie G, Terzolo M. European Society of Endocrinology Clinical Practice Guidelines on the management of adrenocortical carcinoma in adults, in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2018 Oct 1;179(4):G1-G46. doi: 10.1530/EJE-18-0608.
Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardiere C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Muller HH, Skogseid B; FIRM-ACT Study Group. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97. doi: 10.1056/NEJMoa1200966. Epub 2012 May 2.
Related Links
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Lysodren (mitotane) dosing, indications, interactions, adverse effects, and more.
Drug Metabolism
Dehydroepiandrosterone and Dehydroepiandrosterone Sulfate - Health Encyclopedia
Cortisol \| South Tees Hospitals NHS Foundation Trust
Adrenal Cancer Stages
Other Identifiers
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GafREC-Endo202
Identifier Type: -
Identifier Source: org_study_id
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