Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450821
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-02-29
Brief Title:
PROSpECT-PRIOR-2-CHEMO PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official Title:
PROSpECT-PRIOR-2-CHEMO A Feasibility RCT of Novel Dental Intervention PRIORProactive Intensive Oral Review Treatment in Patients Scheduled for Chemotherapy for Myeloma-ASCT Hematological Cancers to Mitigate Chemotherapy Complications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 PRIORPro-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 ie 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 patients 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 infectioninflammation 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
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 ie 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 patients 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 infectioninflammation 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None