Clinical trial NCT02702583: The Oral Cavity as a Source of Febrile Neutropenia
Official title: The Oral Cavity as a Source of Febrile Neutropenia: An Observational Study in Cancer Patients Treated With Myelosuppressive Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Neutropenia
Solid Tumors
Dental Infection
Oral Infection
Keywords: Myelosuppressive Chemotherapy
Febrile Neutropenia
Solid Tumors
Dental Infection
Oral Infection
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients treated with myelosuppressive chemotherapy with a 10-20% estimated risk to develop febrile neutropenia.

Brief summary: Febrile 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 the knowledge on the role of the oral cavity as a potential source of bacteremia.

The investigators expect that the 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dutch Periodontal Screening Index
timeFrame: 1 day
measure: Caries-screening
timeFrame: 1 day
measure: Impacted (wisdom) teeth
timeFrame: 1 day
measure: Plaque index in percentages
timeFrame: 1 day
measure: Radiographically (X-OPT) calculated bone loss in millimeters
timeFrame: 1 day
measure: Peri-apical radiolucency
timeFrame: 1 day
measure: Radix relicta
timeFrame: 1 day
Secondary outcomes:
measure: NCI CTCAE V3.0 mucositis/stomatitis
timeFrame: 100 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: L. Smeele, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: