PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leeds
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Myeloma- Autologous Stem Cell Transplantation (ASCT) before high-dose myeloablative CT.
Haematological cancers suitable for Allografts Stem Cell Transplant (SCT) before CT
Clinical evidence of caries (2+ teeth)
Clinical evidence on soft and hard tissue examination of infection, sinus, swelling or tenderness
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PRIOR [Proactive Intensive Oral Review & Treatment]
Procedure/SurgeryIntervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR \[Proactive Intensive Oral Review \& Treatment\] prior to chemotherapy.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 CT2
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 CT3
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 CT4
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 CTSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leeds
Lead sponsor
The Leeds Teaching Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: