|- candidate number||23979|
|- NTR Number||NTR5761|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-feb-2016|
|- Secondary IDs||NL 53440.018.15 METC|
|- Public Title||THE ORAL CAVITY AS A SOURCE OF FEBRILE NEUTROPENIA
|- Scientific Title||THE ORAL CAVITY AS A SOURCE OF FEBRILE NEUTROPENIA
An observational study in cancer patients treated with myelosuppressive chemotherapy|
|- ACRONYM||ORA-FEBRIS study|
|- hypothesis||The oral cavity plays a role in the development of febrile neutropenia in patients treated with myelosuppressive chemotherapy|
|- Healt Condition(s) or Problem(s) studied||Neutropenia, Oral lesion|
|- Inclusion criteria||- Diagnosed with a solid cancer, lymphoma or multiple myeloma|
- Planned treatment with myelosuppressive chemotherapy with FN risk of 10%-20% (with or without targeted therapies or hormonal therapy)
- Willing and able to give written Informed consent
- Age 18 or older
- Presence of (partial) natural dentition and/or dental implants
|- Exclusion criteria||- Patients unable to give written informed consent |
- Patients <18 years
- Prior irradiation to the head and neck - Edentulous patients
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-dec-2015|
|- planned closingdate||1-dec-2017|
|- Target number of participants||200|
|- Primary outcome||To identify oral/dental foci prior to the start of chemotherapy and to determine whether these are associated with the development of FN, bacteremia and/or SIRS/sepsis|
|- Secondary outcome||To assess whether oral/dental foci are associated with the incidence and severity of OM |
To assess whether OM is associated with FN, bacteremia and SIRS/sepsis
To document microbiological shifts (bacteria/fungi) in oral rinsing samples taken prior to chemotherapy and during standard care visits thereafter using an innovative open-end technique and to investigate any associations with the development of OM
To assess retrospectively whether any microorganisms found in blood samples from patients with FN are (likely) derived from the oral cavity using DNA finger printing techniques and Q-PCR.
To explore whether genetic polymorphisms in candidate genes demonstrate an increased risk for the development of severe OM, FN, and SIRS/sepsis
Differences in inflammation parameters in peripheral blood at baseline and when presenting with fever and/or mucositis.
|- Timepoints||Dental examination prior to first cycle of chemotherapy|
During and after chemotherapy clinical examination of the oral mucosa and oral rinsing sample (until 100 days after first chemotherapy)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.A.E.M. Zecha|
|- CONTACT for SCIENTIFIC QUERIES|| J.A.E.M. Zecha|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||ebrile neutropenia (FN) is a clinically important adverse effect of myelosuppressive chemotherapy. If patients present with FN, attention is focussed on well-recognized sites of origin of infection: the airways, urinary tracts, and skin. However, infections can be only documented clinically in about two-third of febrile episodes, whereas a causative microbial pathogen cannot be identified in the majority (>70%) of cases.
Pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only routinely used in patients at high risk for oral complications (i.e. head and neck cancer patients and stem cell transplantation recipients). However, any patient treated with myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing infection in and/or originating from the oral cavity. Nevertheless, in these patients dental screening is somewhat randomly employed at the oncologistís discretion.|
More insight into the pre-treatment oral condition and its potential role in FN is mandatory, particularly considering the growing numbers of older patients retaining their natural dentition and the increase of dental diseases and cancer incidence with age.
In addition, oral diseases may aggravate chemotherapy-induced oral mucositis (OM). OM is associated with an inflammatory response, which together with ulcerations providing a portal of entry for bacteria, can result in FN and systemic inflammatory syndrome (SIRS) and/or sepsis. Evidence suggests that microorganisms are involved in the pathobiology of OM, but no longitudinal studies using open-end sequencing are available.
Furthermore, comparing bacteria identified in blood cultures in febrile patients with those of the oral cavity will expand our knowledge on the role of the oral cavity as a potential source of bacteremia.
We expect that our results will provide a scientific base for subsequent intervention studies on the efficacy of dental screening and elimination of foci, and other interventions aimed at modifying the oral environment before and during chemotherapy.
|- Main changes (audit trail)|
|- RECORD||16-feb-2016 - 23-mei-2016|