OncologyNCT06450821
PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications
A study testing PRIOR [Proactive Intensive Oral Review & Treatment] in people with Oncology and Periodontitis, run by University of Leeds at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Periodontitis, Myeloma
- What is being tested?
- PRIOR [Proactive Intensive Oral Review & Treatment]
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Dental Translational & Clinical Research Unit (DenTCRU)
Leeds, West Yorkshire, LS29LU
Sue Pavitt, PhD, +44 7939 014659, s.pavitt@leeds.ac.uk
Nuria Navarro-Coy, +44 7967 786733, n.navarro-coy@leeds.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Oncology, Periodontitis, Myeloma, Oral Mucositis, Febrile Neutropenia
- Being tested
- PRIOR [Proactive Intensive Oral Review & Treatment]
- Medical subject headings
- Neoplasms, Periodontitis, Neoplasms, Plasma Cell, Stomatitis, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIOR [Proactive Intensive Oral Review & Treatment]Procedure or surgery
Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR [Proactive Intensive Oral Review \& Treatment] prior to chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Control Arm: NHS standard care pathway delivered. |
| Intervention Arm | Experimental | Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR [Proactive Intensive Oral Review \& Treatment] prior to chemotherapy. Receives: Procedure: PRIOR [Proactive Intensive Oral Review & Treatment] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 100 days from the date of commencement of chemotherapy (about 4 months from randomisation)
Secondary outcomes (13)
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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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
Measured: 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.
Measured: After completion of study, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The moderate and high-risk patients will then be randomised. Those randomised to the PRIOR intervention arm will be assessed in a consultant-led Restorative Dentistry department \& treatment offered to stabilise primary dental diseases (periodontal disease, caries, and odontogenic infection). The treatment plan (by a dentist) will be delivered within the therapeutic window (the PRIOR window), defined as the period between MDT decision to offer ASCT/allo-SCT up to 7 days prior to commencement of CT for ASCT/allo-SCT. Participant treatment plans are highly personalised and therefore number of visits within the therapeutic window to deliver PRIOR are not strictly defined. PRIOR will aim to stabilise the oral health of the participant and remove obvious sources of oral health infection. Participant follow-up will monitor febrile event rate and OM incidence between groups, within the participant therapeutic window, defined as day one of SCT/CT+100 days.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Sue Pavitt, University of Leeds
- Investigators
- Zaid Ali, BChD, Principal investigator, LTHT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450821
- Sponsor's protocol ID
- 296640
- Status last verified
- Jun 2024
- First submitted
- 29 Feb 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raber-Durlacher JE, Epstein JB, Raber J, van Dissel JT, van Winkelhoff AJ, Guiot HF, van der Velden U. Periodontal infection in cancer patients treated with high-dose chemotherapy. Support Care Cancer. 2002 Sep;10(6):466-73. doi: 10.1007/s00520-002-0346-3. Epub 2002 Mar 23.
PubMed 12353125Brennan MT, Elting LS, Spijkervet FK. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO: methodology and quality of the literature. Support Care Cancer. 2010 Aug;18(8):979-84. doi: 10.1007/s00520-010-0856-3. Epub 2010 Mar 20.
PubMed 20306090Jia G, Zhi A, Lai PFH, Wang G, Xia Y, Xiong Z, Zhang H, Che N, Ai L. The oral microbiota - a mechanistic role for systemic diseases. Br Dent J. 2018 Mar 23;224(6):447-455. doi: 10.1038/sj.bdj.2018.217.
PubMed 29569607Zecha JAEM, Raber-Durlacher JE, Laheij AMGA, Westermann AM, Epstein JB, de Lange J, Smeele LE. The impact of the oral cavity in febrile neutropenia and infectious complications in patients treated with myelosuppressive chemotherapy. Support Care Cancer. 2019 Oct;27(10):3667-3679. doi: 10.1007/s00520-019-04925-8. Epub 2019 Jun 20.
PubMed 31222393Laine PO, Lindqvist JC, Pyrhonen SO, Strand-Pettinen IM, Teerenhovi LM, Meurman JH. Oral infection as a reason for febrile episodes in lymphoma patients receiving cytostatic drugs. Eur J Cancer B Oral Oncol. 1992 Oct;28B(2):103-7. doi: 10.1016/0964-1955(92)90036-z.
PubMed 1306727Borowski B, Benhamou E, Pico JL, Laplanche A, Margainaud JP, Hayat M. Prevention of oral mucositis in patients treated with high-dose chemotherapy and bone marrow transplantation: a randomised controlled trial comparing two protocols of dental care. Eur J Cancer B Oral Oncol. 1994;30B(2):93-7. doi: 10.1016/0964-1955(94)90059-0.
PubMed 8032307Tsuji K, Shibuya Y, Akashi M, Furudoi S, Yakushijin K, Kawamoto S, Okamura A, Matsuoka H, Komori T. Prospective study of dental intervention for hematopoietic malignancy. J Dent Res. 2015 Feb;94(2):289-96. doi: 10.1177/0022034514561768. Epub 2014 Dec 10.
PubMed 25503612Zhang X, Zhang D, Jia H, Feng Q, Wang D, Liang D, Wu X, Li J, Tang L, Li Y, Lan Z, Chen B, Li Y, Zhong H, Xie H, Jie Z, Chen W, Tang S, Xu X, Wang X, Cai X, Liu S, Xia Y, Li J, Qiao X, Al-Aama JY, Chen H, Wang L, Wu QJ, Zhang F, Zheng W, Li Y, Zhang M, Luo G, Xue W, Xiao L, Li J, Chen W, Xu X, Yin Y, Yang H, Wang J, Kristiansen K, Liu L, Li T, Huang Q, Li Y, Wang J. The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment. Nat Med. 2015 Aug;21(8):895-905. doi: 10.1038/nm.3914. Epub 2015 Jul 27.
PubMed 26214836Momen-Heravi F, Babic A, Tworoger SS, Zhang L, Wu K, Smith-Warner SA, Ogino S, Chan AT, Meyerhardt J, Giovannucci E, Fuchs C, Cho E, Michaud DS, Stampfer MJ, Yu YH, Kim D, Zhang X. Periodontal disease, tooth loss and colorectal cancer risk: Results from the Nurses' Health Study. Int J Cancer. 2017 Feb 1;140(3):646-652. doi: 10.1002/ijc.30486. Epub 2016 Nov 23.
PubMed 27778343D'Aiuto F, Gkranias N, Bhowruth D, Khan T, Orlandi M, Suvan J, Masi S, Tsakos G, Hurel S, Hingorani AD, Donos N, Deanfield JE; TASTE Group. Systemic effects of periodontitis treatment in patients with type 2 diabetes: a 12 month, single-centre, investigator-masked, randomised trial. Lancet Diabetes Endocrinol. 2018 Dec;6(12):954-965. doi: 10.1016/S2213-8587(18)30038-X. Epub 2018 Oct 24.
PubMed 30472992Konig MF, Abusleme L, Reinholdt J, Palmer RJ, Teles RP, Sampson K, Rosen A, Nigrovic PA, Sokolove J, Giles JT, Moutsopoulos NM, Andrade F. Aggregatibacter actinomycetemcomitans-induced hypercitrullination links periodontal infection to autoimmunity in rheumatoid arthritis. Sci Transl Med. 2016 Dec 14;8(369):369ra176. doi: 10.1126/scitranslmed.aaj1921.
PubMed 27974664Keefe DM, Schubert MM, Elting LS, Sonis ST, Epstein JB, Raber-Durlacher JE, Migliorati CA, McGuire DB, Hutchins RD, Peterson DE; Mucositis Study Section of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer. 2007 Mar 1;109(5):820-31. doi: 10.1002/cncr.22484.
PubMed 17236223
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06450821
- Acronym / sponsor ID
- 296640
- Conditions
- Oncology, Periodontitis, Myeloma, Oral Mucositis, Febrile Neutropenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jun 2024 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The moderate and high-risk patients will then be randomised. Those randomised to the PRIOR intervention arm will be assessed in a consultant-led Restorative Dentistry department \& treatment offered to stabilise primary dental diseases (periodontal disease, caries, and odontogenic infection). The treatment plan (by a dentist) will be delivered within the therapeutic window (the PRIOR window), defined as the period between MDT decision to offer ASCT/allo-SCT up to 7 days prior to commencement of CT for ASCT/allo-SCT. Participant treatment plans are highly personalised and therefore number of visits within the therapeutic window to deliver PRIOR are not strictly defined. PRIOR will aim to stabilise the oral health of the participant and remove obvious sources of oral health infection. Participant follow-up will monitor febrile event rate and OM incidence between groups, within the participant therapeutic window, defined as day one of SCT/CT+100 days.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Control Arm: NHS standard care pathway delivered. |
| Intervention Arm | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Intervention Arm |
Primary outcome
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
13 secondary outcomes
Ability to recruit, recruitment rate and acceptability of randomisation
Time frame: 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
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
Data collection via electronic health records
Time frame: 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
Number of participants developing oral mucositis and returning the OMDQ questionnaire
Time frame: 100 days after CT
Number of participants prescribed an Antibiotic
Time frame: 100 days after CT
Number of participants with hospital admissions and the length of their hospital stays
Time frame: 100 days after CT
Number of participants with other (specified) chemotherapy-related complications
Time frame: 100 days after CT
Number of participants completing Quality of Life Questionnaires
Time frame: 100 days after CT
Rate of Mortality
Time frame: 100 days after CT
Process Evaluation
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 12353125Raber-Durlacher JE, Epstein JB, Raber J, van Dissel JT, van Winkelhoff AJ, Guiot HF, van der Velden U. Periodontal infection in cancer patients treated with high-dose chemotherapy. Support Care Cancer. 2002 Sep;10(6):466-73. doi: 10.1007/s00520-002-0346-3. Epub 2002 Mar 23.
- Background: PubMed 20306090Brennan MT, Elting LS, Spijkervet FK. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO: methodology and quality of the literature. Support Care Cancer. 2010 Aug;18(8):979-84. doi: 10.1007/s00520-010-0856-3. Epub 2010 Mar 20.
- Background: PubMed 29569607Jia G, Zhi A, Lai PFH, Wang G, Xia Y, Xiong Z, Zhang H, Che N, Ai L. The oral microbiota - a mechanistic role for systemic diseases. Br Dent J. 2018 Mar 23;224(6):447-455. doi: 10.1038/sj.bdj.2018.217.
- Background: PubMed 31222393Zecha JAEM, Raber-Durlacher JE, Laheij AMGA, Westermann AM, Epstein JB, de Lange J, Smeele LE. The impact of the oral cavity in febrile neutropenia and infectious complications in patients treated with myelosuppressive chemotherapy. Support Care Cancer. 2019 Oct;27(10):3667-3679. doi: 10.1007/s00520-019-04925-8. Epub 2019 Jun 20.
- Background: PubMed 1306727Laine PO, Lindqvist JC, Pyrhonen SO, Strand-Pettinen IM, Teerenhovi LM, Meurman JH. Oral infection as a reason for febrile episodes in lymphoma patients receiving cytostatic drugs. Eur J Cancer B Oral Oncol. 1992 Oct;28B(2):103-7. doi: 10.1016/0964-1955(92)90036-z.
- Background: PubMed 8032307Borowski B, Benhamou E, Pico JL, Laplanche A, Margainaud JP, Hayat M. Prevention of oral mucositis in patients treated with high-dose chemotherapy and bone marrow transplantation: a randomised controlled trial comparing two protocols of dental care. Eur J Cancer B Oral Oncol. 1994;30B(2):93-7. doi: 10.1016/0964-1955(94)90059-0.
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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.
Zaid Ali, BChD principal investigator
LTHT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIOR [Proactive Intensive Oral Review & Treatment] in people with Oncology and Periodontitis, run by University of Leeds at 1 site in United Kingdom.
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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Jun 2024. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sue H Pavitt, PhD (+44 7939 014 659, s.pavitt@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450821, which also lists 12 linked publications.
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 10 Jun 2024; AzTrials last refreshed its copy on 2 Nov 2026.