The objectives of this pilot study are to explore differences in sleep and fatigue, and the relation with the function of the HPA axis, between survivors of childhood ALL and healthy controls.
ID
Source
Brief title
Condition
- Leukaemias
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Function of the HPA axis will be evaluated with the use of salivatory cortisol
and a low-dose dexamethasone suppression test. Information on sleep, fatigue
and quality of life will be gathered through questionnaires.
Secondary outcome
not applicable
Background summary
There have been important advances in treatment and survival of children with
acute lymphoblastic leukemia (ALL) over the past decades. This success has lead
to increased attention for psycho-social functioning in these children.
Corticosteroids are an important part of treatment and seem to have an adverse
effect on sleep and fatigue, which in turn leads to more psycho-social
problems. Sleep problems and fatigue are also common in adult survivors of
childhood cancer. In healthy children there is a relation between cortisol and
sleep problems. Suppression of the hypothalamic-pituary-adrenal (HPA) axis as a
result of high dose steroids has been found in short and long(er) term
survivors of ALL. No research has yet explored the relation between the use of
steroids, function of the HPA axis and the effect on sleep and fatigue in
children with ALL. More understanding of the influence of high dosed steroids
on disturbed sleep and increased fatigue, and the relation with suppression of
the HPA axis could help improve counselling and quality of life in these
children. This pilot study will explore the relation between function of the
HPA-axis after high dosed steroids and sleep.
Study objective
The objectives of this pilot study are to explore differences in sleep and
fatigue, and the relation with the function of the HPA axis, between survivors
of childhood ALL and healthy controls.
Study design
Cross sectional, multi-centre study.
Children treated for ALL according to the national protocol ALL-9 or ALL-10 at
the VU University Medical Centre or the national protocol ALL-10 at the
Wilhelmina Children's Hospital or the University Medical Center Nijmegen will
be eligible. Friends of the patients will provide for an age and sex matched
healthy control group. Information on the function of the HPA axis will be
collected on two consecutive days. Questionnaires concerning sleep and fatigue
will be distributed.
Study burden and risks
Saliva will collected on seven occasions during two consecutive days.
Questionnaires will be filled out by parents and children over eight years of
age, this will take up to 45 minutes. There are no risks associated with this
study. During previous studies in this population, parents and (older) children
clearly appreciated the attention for psycho-social issues as a result of ALL
treatment. Due to these previous experiences, participation rates in this study
are expected to be high.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- all children that have been treated according to the ALL-9 (VUmc) or ALL-10 (VUmc, WKZ, UMCN) protocol because of acute lymphoblastic leukemie
- fluent in Dutch
Exclusion criteria
- Down syndrome
- Long-term use of corticosteroids for other reasons than ALL
- other chronic or serious conditions, influencing sleep and/or behavior
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 | NL26642.029.09 |