* To estimate the prevalence of hyposalivation and xerostomia in pediatric cancer survivors treated with different cancer regimens (e.g., H&N RT, TBI, CT, or those who developed cGVHD following allogeneic stem cell transplantation).* To describe…
ID
Source
Brief title
Condition
- Salivary gland conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- reduced unstimulated and stimulated salivary flow and Patient Reported
Outcomes indicative for xerostomia
- association between salivary flow measurements and complaints indicative for
xerostomia
- patient and therapy related risk factors for hyposalivation and xerostomia
- association between xerostomia and oral-health-related quality of life
- selected microorganisms and markers related to disease, oral function and
defense mechanisms in oral fluid samples.
Secondary outcome
not applicable
Background summary
Advances in diagnosis and treatment of childhood cancer over the last decades
have dramatically increased long-term survival. As a result, the numbers of
childhood cancer survivors (CCS) are growing and it has become increasingly
clear that the former disease and its treatment can significantly impair
long-term health. The need for long-term follow-up is uniformly recognized.
Research focusing on identification and characterization of high-risk
populations is an essential foundation on which to build evidence-based
recommendations for long-term follow-up. Furthermore, research focusing on more
accurate screening tests and effective interventions is needed to reduce excess
morbidity and mortality in CCS. The SKION LATER Q2008 - hyposalivation study
phocuses on oral toxicity in CCS
Study objective
* To estimate the prevalence of hyposalivation and xerostomia in pediatric
cancer survivors treated with different cancer regimens (e.g., H&N RT, TBI, CT,
or those who developed cGVHD following allogeneic stem cell transplantation).
* To describe if any concordance is present between objective salivary flow
measurements and patient-reported outcomes indicative for xerostomia.
* To assess putative patient-related and therapy-related risk factors.
* To examine the association between xerostomia and oral-health-related quality
of life.
* To assess selected microbiological parameters and (glyco)proteins in whole
salivary samples that are associated with oral infection, defense mechanisms or
thirst sensation.
Study design
This study involves measurement of unstimulated and stimulated salivary flow
and taking of a whole saliva sample. Also, an oral health questionnaire will be
completed by the study participants.
(This study is part of a larger late effects study as described)
Study burden and risks
The burden is limited since investigation of salivary production is not painful
and invasiveness is limited. No risks associated.
Heidelberglaan 25
Utrecht 3584CS
NL
Heidelberglaan 25
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
All patients who were treated for childhood cancer (before age 18) in one of
the Pediatric Oncology Centers between 1960 and 2001 and who survived for at
least 5 years after diagnosis will be included in the SKION LATER study.
Participating centres are located in Amsterdam (VU University Medical Center
(VUMC)), Groningen (Children's Cancer Center/ University Medical Center
Groningen (UMCG)), Rotterdam (Rotterdam Erasmus MC-Sophia (REMC-S), Nijmegen
(University Medical Center Nijmegen (UMCN)), Leiden (Leiden University Medical
Center (LUMC) and Utrecht (Princess Máxima Center for Pediatric Oncology
(PMC)). From this cohort, 300 childhood cancer survivors (100 who received
irradiation to head or neck, 100 with a history of chronic graft versus host
disease and 100 treated with chemotherapy but not with radiotherapy) will be
asked to participate in the salivary study
Exclusion criteria
diagnosis of childhood cancer with survival less than 5 years, age at diagnosis
>17 years or diagnosis while residing in foreign country
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 | NL35042.018.11 |