The Oral Cavity as a Source of Febrile Neutropenia

NCT02702583 | Completed

• 1 other identifier: NL53440.018.15
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Neutropenia; Solid Tumors; Dental Infection; Oral Infection

Keywords

Myelosuppressive Chemotherapy; Febrile Neutropenia; Solid Tumors; Dental Infection; Oral Infection

Outcome Measures

Primary Outcomes (7)

• 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 1. No pockets \>3mm in depth, no calculus, no overhangs of restorations, but presence of bleeding on probing to the bottom of the pocket 2. No pockets \>3mm in depth, presence of bleeding on probing to the bottom of the pocket, and presence of calculus or overhanging restorations 3. Presence of pathological pockets of 4-5mm without gingival recession 4. Presence of pathological pockets of 4-5mm with gingival recession 5. 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

• Caries-screening

  1. no caries 2. caries in enamel 3. caries \<50% in dentin 4. caries \>50% in dentin 5. caries in rootcanal

  1 day

• Impacted (wisdom) teeth

  1. not impacted 2. partially impacted 3. impacted

  1 day

• 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

• 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

• Peri-apical radiolucency

  Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as 1. yes 2. no

  1 day

• Radix relicta

  The presence of radix relicta is noted as 1. yes 2. no

  1 day

Secondary Outcomes (1)

• NCI CTCAE V3.0 mucositis/stomatitis

  100 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients treated with myelosuppressive chemotherapy with a 10-20% estimated risk to develop febrile neutropenia.

You may qualify if:

• 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

You may not qualify if:

• Patients unable to give written informed consent
• Patients \<18 years
• Prior irradiation to the head and neck
• Edentulous patients

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Oral rinsing samples Saliva samples

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• L. Smeele, Professor, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 8, 2016
• Study Start: December 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

NL (1)