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NCT Number: NCT02702583

The Oral Cavity as a Source of Febrile Neutropenia

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.

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Key information

Conditions

Febrile Neutropenia Agranulocytosis Cytopenia Dental Infection Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia Oral Infection Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dutch Periodontal Screening Index

    Time frame: 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.

  2. Caries-screening

    Time frame: 1 day

    • no caries
    • caries in enamel
    • caries <50% in dentin
    • caries >50% in dentin
    • caries in rootcanal

  3. Impacted (wisdom) teeth

    Time frame: 1 day

    • not impacted
    • partially impacted
    • impacted

  4. Plaque index in percentages

    Time frame: 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.

  5. Radiographically (X-OPT) calculated bone loss in millimeters

    Time frame: 1 day

    Bone loss is measured on a X-OPT and the average bone loss is noted in millimeters.

  6. Peri-apical radiolucency

    Time frame: 1 day

    Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as

    • yes
    • no

  7. Radix relicta

    Time frame: 1 day

    The presence of radix relicta is noted as

    • yes
    • no

Secondary outcomes

  1. NCI CTCAE V3.0 mucositis/stomatitis

    Time frame: 100 days

    The NCI-CTCAE v3.0 mucositis/stomatitis is noted for every patient when visiting the hospital.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: ORA-FEBRIS

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Mar 8, 2016
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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