Febrile NeutropeniaORA-FEBRISNCT02702583
The Oral Cavity as a Source of Febrile Neutropenia
An observational study of Febrile Neutropenia and Solid Tumors, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia, Solid Tumors, Dental Infection
- How many people
- 94 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2015to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated with myelosuppressive chemotherapy with a 10-20% estimated risk to develop febrile neutropenia.
Who may be able to join
- 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
Who cannot join
- Patients unable to give written informed consent
- Patients <18 years
- Prior irradiation to the head and neck
- Edentulous patients
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
About this study
Official title: The Oral Cavity as a Source of Febrile Neutropenia: An Observational Study in Cancer Patients Treated With Myelosuppressive Chemotherapy
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.
Read more
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
- Medical subject headings
- Febrile Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Caries-screening
- no caries
- caries in enamel
- caries <50% in dentin
- caries >50% in dentin
- caries in rootcanal
Measured: 1 day
Impacted (wisdom) teeth
- not impacted
- partially impacted
- impacted
Measured: 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.
Measured: 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.
Measured: 1 day
Peri-apical radiolucency
Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as
- yes
- no
Measured: 1 day
Radix relicta
The presence of radix relicta is noted as
- yes
- no
Measured: 1 day
Secondary outcomes (1)
NCI CTCAE V3.0 mucositis/stomatitis
The NCI-CTCAE v3.0 mucositis/stomatitis is noted for every patient when visiting the hospital.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startDec 2015
- Primary completion31 Dec 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.A.E.M. Zecha, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- L. Smeele, Professor, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702583
- Sponsor's protocol ID
- NL53440.018.15
- Acronym
- ORA-FEBRIS
- Status last verified
- Nov 2021
- First submitted
- 22 Feb 2016
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oral Cavity as a Source of Febrile Neutropenia: An Observational Study in Cancer Patients Treated With Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT02702583
- Acronym / sponsor ID
- ORA-FEBRIS / NL53440.018.15
- Conditions
- Febrile Neutropenia, Solid Tumors, Dental Infection, Oral Infection
- Keywords
- Myelosuppressive Chemotherapy, Febrile Neutropenia, Solid Tumors, Dental Infection, Oral Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with myelosuppressive chemotherapy with a 10-20% estimated risk to develop febrile neutropenia.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patients unable to give written informed consent
- Patients <18 years
- Prior irradiation to the head and neck
- Edentulous patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
Caries-screening
Time frame: 1 day
1. no caries 2. caries in enamel 3. caries <50% in dentin 4. caries >50% in dentin 5. caries in rootcanal
Impacted (wisdom) teeth
Time frame: 1 day
1. not impacted 2. partially impacted 3. impacted
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.
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.
Peri-apical radiolucency
Time frame: 1 day
Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as 1. yes 2. no
Radix relicta
Time frame: 1 day
The presence of radix relicta is noted as 1. yes 2. no
1 secondary outcome
NCI CTCAE V3.0 mucositis/stomatitis
Time frame: 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Smeele, Professor, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia and Solid Tumors, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dutch Periodontal Screening Index (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.