PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications

June 4, 2024 updated by: Sue Pavitt, University of Leeds

PROSpECT-PRIOR-2-CHEMO: A Feasibility RCT of Novel Dental Intervention PRIOR[Proactive Intensive Oral Review & Treatment] in Patients Scheduled for Chemotherapy for Myeloma-ASCT & Hematological Cancers to Mitigate Chemotherapy Complications

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS29LU
        • Dental Translational & Clinical Research Unit (DenTCRU)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zaid Ali, BChD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (mod-high/risk trial participants):

  • Adults (≥ 18years) with scheduled Chemotherapy. Specifically, patients who meet the following diagnosis and treatment window requirements:

    • Myeloma- Autologous Stem Cell Transplantation (ASCT) before high-dose myeloablative CT.
    • Haematological cancers suitable for Allografts Stem Cell Transplant (SCT) before CT

  • Moderate / High Oral Health Risk Assessment - any one of the following:

    • Clinical evidence of caries (2+ teeth)
    • Clinical evidence on soft and hard tissue examination of infection, sinus, swelling or tenderness
    • BPE code 3-4 in any remaining sextant
    • BPE code 1-2 with >30% BOP
  • The patient is fully informed, has received PIS (patient information sheet) and considered during a 'cooling-off' period, is competent to consent, and is able to comply with minimum attendance requirements

Exclusion Criteria:

  • Have a history of head and neck radiotherapy
  • Have been treated with Denusomab, Bevacizumab, Sunitinib or Aflibercept within 9 months of the MDT date.
  • Insufficient teeth [defined as <2]
  • Are incapable of providing informed written consent
  • Are unable to comply with minimum attendance requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Control Arm: NHS standard care pathway delivered.
Experimental: Intervention Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants able to attend treatment sessions required for completion of treatment plan, within the defined chemotherapy therapeutic window.
Time Frame: 100 days from the date of commencement of chemotherapy (about 4 months from randomisation)
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
100 days from the date of commencement of chemotherapy (about 4 months from randomisation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to recruit, recruitment rate and acceptability of randomisation
Time Frame: Prior to commencement of CT and 100 days after CT

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.
Prior to commencement of CT and 100 days after CT
Patient compliance with dental referral and treatment plan
Time Frame: Prior to commencement of CT and 100 days after CT

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
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
Time Frame: Prior to commencement of CT and 100 days after CT
Baseline samples collected by dental team, febrile events collected by oncology team.
Prior to commencement of CT and 100 days after CT
Data collection via electronic health records
Time Frame: Prior to commencement of CT and 100 days after CT
E.g Oral mucositis and febrile events. Electronic health records accessed by dental team (with patients consent)
Prior to commencement of CT and 100 days after CT
Number of participants developing sepsis/bloodstream infection/febrile events
Time Frame: 100 days after CT
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]
100 days after CT
Number of participants developing oral mucositis and returning the OMDQ questionnaire
Time Frame: 100 days after CT
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]
100 days after CT
Number of participants prescribed an Antibiotic
Time Frame: 100 days after CT
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]
100 days after CT
Number of participants with hospital admissions and the length of their hospital stays
Time Frame: 100 days after CT
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]
100 days after CT
Number of participants with other (specified) chemotherapy-related complications
Time Frame: 100 days after CT
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]
100 days after CT
Number of participants completing Quality of Life Questionnaires
Time Frame: 100 days after CT
(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]
100 days after CT
Rate of Mortality
Time Frame: 100 days after CT
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]
100 days after CT
Process Evaluation
Time Frame: post 100 days
Acceptability of delivery of PRIOR to participants and clinical delivery teams in haematology and dental departments - Focus group/Interviews
post 100 days
Inform the design of a definitive RCT. Specifically, whether haematological cancer groups can be combined for efficiency
Time Frame: After completion of study, approximately 18 months
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.
After completion of study, approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Zaid Ali, BChD, LTHT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 296640

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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