NCT06861530

A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children

A Swiss Prospective Multicenter Longitudinal Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children: An Explorative Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University Children's Hospital Basel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Plain Language Summary: Background Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning. To treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. This helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency. This deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. Moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect. Objectives The aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. Additionally, the goal is to identify which children are at particularly high risk. By gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer. Methods Regular low-dose ACTH tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. To avoid placing additional burden on children who are already heavily affected by the disease, we will only perform these tests when there is already a venous access established and the children are in the hospital for treatment reasons.

Conditions

• Adrenal Insufficiency
• Leukemia, Lymphoblastic, Acute, Pediatric
• Lymphoma, Lymphoblastic

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

2 sites across 1 country: Switzerland