RecruitingNCT06861530

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


Sponsor

University Children's Hospital Basel

Enrollment

40 participants

Start Date

Aug 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is checking whether children treated with steroid medicines (glucocorticoids) for leukemia or lymphoma develop problems with their adrenal glands — the glands responsible for making the body's own stress hormones — after stopping the steroids. **You may be eligible if...** - Your child has been diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) - Your child has been treated with steroids continuously for at least 21 days - Treatment occurred at the Children's University Hospital of Basel or the Children's Hospital of Aarau between July 2024 and June 2027 - A parent or guardian (and the child if 14 or older) can provide informed consent within week 2 of steroid treatment **You may NOT be eligible if...** - Your child has a known allergy to the synthetic ACTH used to test adrenal function (Synacthen) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

KSA

Aarau, Switzerland

UKBB

Basel, Switzerland

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NCT06861530


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