PROSpECT-PRIOR-2-CHEMO
Research type
Research Study
Full title
PROSpECT-PRIOR-2-CHEMO: A pilot RCT efficacy, mechanistic & process evaluation of a novel dental intervention PRIOR (Proactive Intensive Oral Review & Treatment) in patients scheduled for chemotherapy for myeloma-ASCT, breast or colorectal cancer to mitigate febrile episodes and oral mucositis (OM)
IRAS ID
296640
Contact name
S Pavitt
Contact email
Sponsor organisation
The University of Leeds
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
Patients with cancer often need chemotherapy, these patients develop a lowered immunity and can be more susceptible to infections. If a patient has gum disease (periodontal disease), or has decayed teeth, bacteria can spread from the mouth to the body. For people on chemo with poor immunity, these bacteria can cause fatal infections. A minor infection can become serious and life-threatening very quickly.
PROSpECT PRIOR-2-CHEMO tests if there is value in introducing a new oral health intervention before chemotherapy, and if this reduces infections and mouth ulcers. The study will test if treating gum disease and removing infected teeth stops bacteria spreading from the mouth via the blood to the rest of the body, and help prevent fever and infections (febrile events) and mouth ulcers (oral mucositis).
PRIOR [PRIOR= PRoactive Intensive Oral Review & Treatment] is a novel interdisciplinary intervention that will be delivered in the time before cancer patients start scheduled chemotherapy. Recruitment will be via local co-investigator oncology teams, recruiting 120 patients from three cancer cohorts 1) myeloma-ASCT, 2) Breast and 3) colorectal, scheduled to receive chemotherapy. Eligible patients will be consented and randomised. Patients will be randomised into two groups: Group one will receive the dental intervention, (PRIOR) to remove as many sources of bacteria as possible. Group two will receive usual care, oral advice.
Patients will be followed up for a period of 100 days post chemotherapy. Follow up will assess the rate of adverse events, specifically life-threatening febrile episodes and painful oral mucositis in each cohort. This pilot study will strengthen confidence and test feasibility parameters before commitment to the full trial.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
21/NW/0337
Date of REC Opinion
1 Feb 2022
REC opinion
Further Information Favourable Opinion