An interventional study of PRIOR [Proactive Intensive Oral Review & Treatment] in Oncology, Periodontitis and Myeloma, sponsored by University of Leeds. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by University of Leeds · Not applicable, Interventional, and Supportive care
The aim of this feasibility trial is to determine if it is safe and feasible to treat oral health diseases in people with haematological cancers before they start their chemotherapy to reduce complications and disruption to planned chemotherapy dose or schedule.
PROSpECT PRIOR-2-CHEMO is a feasibility trial which will determine if it is safe and feasible to introduce a new oral health (OH) "PRIOR"(Pro-Active Intensive Oral Review and Treatment prior to chemotherapy) intervention for people with cancer, prior to receiving chemotherapy (CT). PRIOR is a novel interdisciplinary intervention that will be introduced into the current oncology pathway and mirrors the specialist Restorative Dental pathway for patients undergoing treatment for Head and Neck cancers. PRIOR is aimed to be delivered within the relatively short therapeutic window that oncology patients have before commencing their scheduled CT for 1) myeloma-ASCT, or 2) Haematological Allograft SCT . This feasibility phase is valuable to inform a definitive trial. The definitive trial would provide important efficacy and mechanistic understanding of the mitigation of CT adverse events (Aes), specifically life-threatening febrile episodes and painful oral mucositis (OM).
The oral microbiome homeostasis is affected by CT; infection risk is exacerbated by OM, and other dental conditions like periodontal disease (PD) that damage the mucosa, caries, and acute / chronic odontogenic abscesses that collectively predispose to systemic translocation of oral-derived bacteria. With about 35% of the adult population affected by moderate and 10-15% severe periodontitis the importance of improving oral health and reducing bacteria load and portals of entry before CT is logical but seldom undertaken.
Bacteria are responsible for the two most prevalent human oral biofilm-mediated diseases: dental caries and periodontitis. Periodontitis is a chronic disease caused by inflammatory reactions to gram negative anaerobic bacteria, resulting in irreversible destruction to oral hard and soft tissues. Local inflammation and tissue damage allow oral bacteria to enter the bloodstream. These Immunocompromised patients (such as those receiving CT) are highly susceptible to these invading pathogens which can manifest as life-threatening systemic infections. The risk of developing systemic infections may be associated with the severity of periodontitis (i.e. the total surface area of the ulcerated pocket epithelium) and the composition periodontal pocket microbiota composition. OM is also an inflammatory condition affecting the oral mucosa. OM is a CT-induced complication that not only affects patient's quality of life but also acts as a portal for oral microorganisms and inflammatory products to translocate into the systemic circulation via the ulcerated mucosa. Pre-existing poor oral and periodontal health is a significant risk factors for CT-induced febrile events, creating therapeutic opportunity.
Oral infection, especially periodontitis, may affect the course and pathogenesis of a number of systemic diseases, including cancer, diabetes, and rheumatoid arthritis. The definitive trial will be a hypothesis-driven, mechanistic trial to understand the novel PRIOR intervention vs current NHS standard of care. Specifically, how PRIOR may mitigate Aes across a range of cancer types and CT regimens. The definitive aim is to understand how PRIOR impacts the oral microbial load, the portal entry sites, and the relationship between the oral microbiome, dysbiosis and systemic infection. The investigators will knowledge transfer from mechanistic evaluation of PD in rheumatoid arthritis showing the oral and gut microbiomes were perturbed but partly normalized after treatment. PD shares common mechanisms of action infection/inflammation across several systemic diseases.
Clinical guidelines recommend seeking dental care prior to CT, this may include recommendation to seek dental care with a general dental practitioner (GDP, Primary care), but uptake is low and established care pathways are rare. Consequently, there has been little direct clinical observation by oncology teams of the value of including dental review; In part due to low advocacy by the oncology team, fuelled by little direct clinical observation of the value of including dental review. Patients report significant barriers to achieving dental care prior to CT including access to a GDP, lack of perceived need and logistical challenges.
Patients do not prioritise seeking dental services as they are unaware of the potential importance to their oncology outcomes. The approach is to provide a specialist consultant-led hospital dental team review mirroring the specialist Restorative Dental pathway undertaken by patients having Head and Neck cancer treatment. Specialist dental teams within a secondary care setting may be better placed to deliver inter-disciplinary care than a GDP due to the time limited therapeutic window (therapeutic window defined as the period between diagnosis and deliver of CT). This work is the first to address the clinical need across several cancer patient groups.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (mod-high/risk trial participants):
Adults (≥ 18years) with scheduled Chemotherapy. Specifically, patients who meet the following diagnosis and treatment window requirements:
Moderate / High Oral Health Risk Assessment - any one of the following:
Exclusion Criteria:
Control Arm: NHS standard care pathway delivered.
Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR \[Proactive Intensive Oral Review \& Treatment\] prior to chemotherapy.
Procedure: PRIOR [Proactive Intensive Oral Review & Treatment]
Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR \[Proactive Intensive Oral Review \& Treatment\] prior to chemotherapy.
Number of participants able to attend treatment sessions required for completion of treatment plan, within the defined chemotherapy therapeutic window.
Ability to deliver individualised planned PRIOR intervention within the defined chemotherapy therapeutic window (no less than 7 days before the start of ASCT/allo-SCT) - Number of patients able to attend sessions required by treatment plan
Time frame: 100 days from the date of commencement of chemotherapy (about 4 months from randomisation)
Ability to recruit, recruitment rate and acceptability of randomisation
Patients identified by oncology team, suitable for treatment within allotted time frame. Number of participants identified by oncology team and enrolled onto intervention vs standard of care arm.
Time frame: Prior to commencement of CT and 100 days after CT
Patient compliance with dental referral and treatment plan
Attrition rates. Ability to complete treatment within desired timeframe. Patients may not attend appointments due to various factors e.g. illness, timing etc. Consent withdrawal from treatment, patients understanding of treatment etc. Measured by number of patients identified to number of participants who complete treatment
Time frame: Prior to commencement of CT and 100 days after CT
Ability to collect samples (baseline and febrile events) for trial biobank future oral biology testing/mechanistic evaluation
Baseline samples collected by dental team, febrile events collected by oncology team.
Time frame: Prior to commencement of CT and 100 days after CT
Data collection via electronic health records
E.g Oral mucositis and febrile events. Electronic health records accessed by dental team (with patients consent)
Time frame: Prior to commencement of CT and 100 days after CT
Number of participants developing sepsis/bloodstream infection/febrile events
Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Number of participants developing oral mucositis and returning the OMDQ questionnaire
Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Number of participants prescribed an Antibiotic
Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Number of participants with hospital admissions and the length of their hospital stays
Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Number of participants with other (specified) chemotherapy-related complications
Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Number of participants completing Quality of Life Questionnaires
(EORTC QLQ-C30; QLQ-OH15) Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Rate of Mortality
Feasibility of collecting clinical assessments from electronic health records /PROMS \[This will also support primary outcome selections and inform power calculations assumptions for a definitive trial\]
Time frame: 100 days after CT
Process Evaluation
Acceptability of delivery of PRIOR to participants and clinical delivery teams in haematology and dental departments - Focus group/Interviews
Time frame: post 100 days
Inform the design of a definitive RCT. Specifically, whether haematological cancer groups can be combined for efficiency
Ability to perform a power calculation to inform a future trial the ideal number of sites required, to make informed decisions about stop/go progression criteria to monitor the trial's progress effectively.
Time frame: After completion of study, approximately 18 months
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Leeds