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

Completed

Conditions: fever
10002252
10027656

Registration Number: NL-OMON50743

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters/endpoints<br /><br>- The presence of oral/dental foci prior to the start of chemotherapy<br /><br>- The development of FN, bacteremia and/or or SIRS/sepsis </p><br>

Secondary Outcome Measures

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