The oral cavity as a source of febrile neutropenia, an observational study in cancer patients treated with myelosuppressive chemotherapy

The oral cavity as a source of febrile neutropenia, an observational study in cancer patients treated with myelosuppressive chemotherapy - ORA-FEBRIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50743

Enrollment

200

Registered

2015-09-23

Start date

2015-12-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fever

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria: - Unable to give written informed consent - Age under 18 years - Prior irradiation to the head and neck - Edentulous patients

Design outcomes

Primary

Measure	Time frame
Primary study parameters/endpoints - The presence of oral/dental foci prior to the start of chemotherapy - The development of FN, bacteremia and/or or SIRS/sepsis	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints: - The presence of oral/dental foci and the incidence and severity of OM - The presence of ulcerative OM and its relative contribution to FN, bacteremia and SIRS/sepsis - The oral microbiome (bacteria/fungi) assessed by open-end sequencing in rinsing samples taken prior to chemotherapy and during routine visits for a period of 100 days following the first administration of chemotherapy - Microorganisms identified in diagnostic blood samples from patients presenting with FN compared retrospectively with oral cavity microorganisms using DNA finger printing techniques and Q-PCR. - To explore whether genetic polymorphisms in candidate genes demonstrate an increased risk for the development of severe OM, FN, and SIRS/sepsis - Differences in inflammation parameters in peripheral blood at baseline and when presenting with fever and/or mucositis.	—

Measure

Time frame

Secondary study parameters/endpoints: - The presence of oral/dental foci and the incidence and severity of OM - The presence of ulcerative OM and its relative contribution to FN, bacteremia and SIRS/sepsis - The oral microbiome (bacteria/fungi) assessed by open-end sequencing in rinsing samples taken prior to chemotherapy and during routine visits for a period of 100 days following the first administration of chemotherapy - Microorganisms identified in diagnostic blood samples from patients presenting with FN compared retrospectively with oral cavity microorganisms using DNA finger printing techniques and Q-PCR. - To explore whether genetic polymorphisms in candidate genes demonstrate an increased risk for the development of severe OM, FN, and SIRS/sepsis - Differences in inflammation parameters in peripheral blood at baseline and when presenting with fever and/or mucositis.

—

Countries

Netherlands

Outcome results