The Oral Cavity as a Source of Febrile Neutropenia

Solid Tumors Clinical Trial

— ORA-FEBRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702583
• Other study ID #: NL53440.018.15
• Status: Completed
• Start date: December 2015
• Est. completion date: January 2021

Study information

• Verified date: November 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Infection
• Febrile Neutropenia
• Fever
• Hyperthermia
• Infections
• Neutropenia
• Oral Infection
• Solid Tumors

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dutch Periodontal Screening Index	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.	1 day
Primary	Caries-screening	no caries; caries in enamel; caries <50% in dentin; caries >50% in dentin; caries in rootcanal	1 day
Primary	Impacted (wisdom) teeth	not impacted; partially impacted; impacted	1 day
Primary	Plaque index in percentages	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.	1 day
Primary	Radiographically (X-OPT) calculated bone loss in millimeters	Bone loss is measured on a X-OPT and the average bone loss is noted in millimeters.	1 day
Primary	Peri-apical radiolucency	Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as; yes; no	1 day
Primary	Radix relicta	The presence of radix relicta is noted as; yes; no	1 day
Secondary	NCI CTCAE V3.0 mucositis/stomatitis	The NCI-CTCAE v3.0 mucositis/stomatitis is noted for every patient when visiting the hospital.	100 days