ORA-FEBRIS: The Oral Cavity as a Source of Febrile Neutropenia

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Completed

CT.gov ID

NCT02702583

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Febrile Neutropenia Solid Tumors Dental Infection Oral Infection

Study Design

Study Type:

Observational

Actual Enrollment :

94 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Oral Cavity as a Source of Febrile Neutropenia: An Observational Study in Cancer Patients Treated With Myelosuppressive Chemotherapy

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jan 1, 2021

Outcome Measures

Primary Outcome Measures

Dutch Periodontal Screening Index [1 day]
Score Clinical criteria for the score per sextant (note site per sextant with the highest score) 0 No pockets >3mm in depth, no calculus, no overhanging restorations and no bleeding on probing to the bottom of the pocket No pockets >3mm in depth, no calculus, no overhangs of restorations, but presence of bleeding on probing to the bottom of the pocket No pockets >3mm in depth, presence of bleeding on probing to the bottom of the pocket, and presence of calculus or overhanging restorations Presence of pathological pockets of 4-5mm without gingival recession Presence of pathological pockets of 4-5mm with gingival recession Presence of pathological pockets of 6mm or more. Ref: Van der Velden U, (2009) J Clin Periodontol. 2009 Dec;36(12):1018-24. doi: 10.1111/j.1600-051X.2009.01495.x. The Dutch periodontal screening index validation and its application in The Netherlands.
Caries-screening [1 day]
no caries caries in enamel caries <50% in dentin caries >50% in dentin caries in rootcanal
Impacted (wisdom) teeth [1 day]
not impacted partially impacted impacted
Plaque index in percentages [1 day]
The plaque index is calculated via the amount of plaque on the mesiobuccal+buccal+distobuccal+mesiopalatinal or mesiolingual+palatinal or lingual+distopalatinal or distolingual of every tooth, given in percentages.
Radiographically (X-OPT) calculated bone loss in millimeters [1 day]
Bone loss is measured on a X-OPT and the average bone loss is noted in millimeters.
Peri-apical radiolucency [1 day]
Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as yes no
Radix relicta [1 day]
The presence of radix relicta is noted as yes no

Secondary Outcome Measures

NCI CTCAE V3.0 mucositis/stomatitis [100 days]
The NCI-CTCAE v3.0 mucositis/stomatitis is noted for every patient when visiting the hospital.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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