To study HPA axis regulation and sympathetic nervous system activity in survivors of childhood ALL during relaxation and during stress.
ID
Source
Brief title
Condition
- Leukaemias
- Adrenal gland disorders
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
HPA axis regulation (cortisol) and sympathetic nervous system activity (blood
pressure, heart rate) during relaxation and during the Trier social stress
test.
Secondary outcome
The association between HPA axis activity and sympathetic nervous system
activity and fatigue and quality of life.
Background summary
The results of a previous study, the DREAMS I study, showed an increased
baseline activity and an enhanced feedback sensitivity of the HPA axis in
survivors of childhood ALL. A plausible explanation for the altered HPA axis
regulation is the presence of stress, in its various guises. Stress also
activates the sympathetic nervous system. Increased sympathetic outflow has
clinical implications, since it is associated with the development of the
metabolic syndrome. Indeed, it is known that survivors of childhood ALL are at
increased risk for the metabolic syndrome.
Study objective
To study HPA axis regulation and sympathetic nervous system activity in
survivors of childhood ALL during relaxation and during stress.
Study design
For this multicenter observational study, all 65 participants of our previous
DREAMS I study will be invited. During a relaxation period and during the Trier
Social Stress Test adapted for children, consisting of a speech task and
arithmetic, saliva cortisol levels and sympathetic outflow which is monitored
by a non-invasive device will be measured.
Study burden and risks
To perform reliable research on HPA axis function in childhood, this study can
not be performed in other subjects than children, for the most part minors.
However, the risks of this study are negligible and the possible objections are
minimal. The participants will complete a questionnaire at home regarding
fatigue and regarding quality of life. In addition, they will be invited for
one afternoon in the hospital to perform a Trier Social Stress Test.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
All subjects from the VUmc, the UMCU and the UMCN that have been treated according to the Dutch Childhood Oncology Group (DCOG) ALL-9 or ALL-10 protocol and that participated in the DREAMS I study.
Healthy age and sex matched controls, existing of: 1) friends of ALL survivors who participate in the DREAMS study, 2) friends of current ALL patients in the VUmc, 3) friends of survivors of childhood cancer who visit the outpatient clinic late effects of the VUmc.
Exclusion criteria
Prolonged glucocorticoid therapy for other reasons than treatment for ALL.
Chronic health conditions that might influence HPA axis activity.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38017.029.11 |