The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma

Adrenocortical Carcinoma Clinical Trial

— MEET  

Official title:

The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05839886
• Other study ID #: CCEMD
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Luming Wu, PhD
• Phone: +86-021-64370045
• Email: wulum[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This work will evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Description:

Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence.

Aims: Evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Methods: Cortisol, ACTH, Gastrointestinal reactions and CNS Toxicity will be measured. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Patients will be included, within ACC with mitotane. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Age = 18 years old and = 75 years Diagnosis of Patients with adrenocortical cancer Gender:

males and females Provide written informed consent Satisfactory compliance

Exclusion Criteria:

Patients with renal insufficiency (Cr>2 times the upper limit of normal). Patients with a history of liver cirrhosis. Patients who are currently using corticosteroids. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%).

Patients with stroke and acute myocardial infarction in the past 6 months. Patients during pregnancy and lactation

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of adverse effects	Adverse effects will be documented using the NCI CTC AE v5	from starting mitotane treatment until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years)
Secondary	Tumor treatment response	According to RECIST (version 1.1).	2 years