No registrations found.
ID
Source
Brief title
Health condition
Febrile neutropenia
Dental focus/foci
Febriele neutropenie
Dentogeen focus/foci
Sponsors and support
Intervention
Outcome measures
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.
Background 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 oncologist’s 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.
Study objective
The oral cavity plays a role in the development of febrile neutropenia in patients treated with myelosuppressive chemotherapy
Study design
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)
Intervention
none
J.A.E.M. Zecha
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
020-5661835
j.zecha@amc.uva.nl
J.A.E.M. Zecha
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
020-5661835
j.zecha@amc.uva.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5646 |
| NTR-old | NTR5761 |
| CCMO | NL53440.018.15 |
| OMON | NL-OMON50743 |