Not yet recruitingNAINTERVENTIONAL

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

This study, called PROSpECT-PRIOR-2-CHEMO, is looking into whether a special dental care plan can help people with certain blood cancers when they are about to start chemotherapy. The plan, called PRIOR, involves thoroughly checking and treating any dental problems, like gum disease or tooth decay, before chemotherapy begins. The main goal is to see if this approach is safe and practical for hospitals to offer. Researchers hope that by fixing dental issues beforehand, patients might experience fewer complications like painful mouth sores (oral mucositis) and serious infections (febrile neutropenia) that can sometimes disrupt their cancer treatment. This first step aims to gather important information for a larger study later on.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Leeds

Enrolment target

Start

01 Jul 2024

Estimated completion

01 Oct 2026

Oncology Periodontitis Myeloma Oral Mucositis Febrile Neutropenia

What is this study about?

When you're about to have chemotherapy for certain blood cancers, your body can become more vulnerable. This study is exploring a new way to help protect you during this time, focusing specifically on your teeth and gums. It's called PROSpECT-PRIOR-2-CHEMO, and it looks at whether giving your mouth a thorough check-up and treatment *before* you start chemotherapy can make a real difference.

You might be wondering why your teeth matter so much during cancer treatment. Well, chemotherapy can sometimes weaken your body's defences, and this can make existing problems in your mouth, like gum disease or tooth decay, much worse. These problems can lead to painful mouth sores (which doctors call oral mucositis) or even serious infections that can get into your bloodstream, causing fevers and potentially delaying your cancer treatment. The PROSpECT study aims to prevent these issues by getting your mouth as healthy as possible beforehand, using a plan called PRIOR.

The PRIOR plan is a new approach adapted from how people with head and neck cancers get their mouths checked before treatment. It means dental specialists would work closely with your cancer team to ensure any dental issues are sorted out in the short time you have before chemotherapy starts. This first part of the study is a 'feasibility trial', which means doctors are checking if this PRIOR plan is safe and practical to carry out in hospitals. If it works well, it could lead to much bigger studies that show exactly how much it helps patients avoid complications and have a smoother chemotherapy journey.

Key takeaways

This study looks at dental care *before* chemotherapy for certain blood cancers.
The 'PRIOR' plan aims to prevent mouth sores and infections during chemotherapy.
It's a 'feasibility study' to see if this dental care plan is safe and practical.
Participation involves thorough dental checks and any necessary treatments.
Good oral health before chemotherapy could make your treatment journey easier.

Who may be eligible?

This study is designed for adults aged 18 or over who are scheduled to have specific types of chemotherapy for blood cancers. This includes people with Myeloma who are having a particular type of stem cell transplant, or others with blood cancers who are having a different kind of stem cell transplant.

You would also need to have some signs of moderate to high oral health risk. This could mean having a couple of teeth with cavities, signs of infection like swelling or tenderness in your mouth, or certain types of gum disease. You also need to be able to understand the study, agree to take part after thinking about it, and be able to attend any appointments required.

However, some people won't be able to join. This includes if you've had radiotherapy to your head or neck in the past, or if you've been treated with certain medications (like Denusomab, Bevacizumab, Sunitinib, or Aflibercept) in the last nine months. If you have fewer than two teeth, or if you can't give your consent or come to the appointments, you also won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for chemotherapy for Myeloma (ASCT) or another blood cancer (Allograft SCT)?
Do you have some signs of dental problems, like cavities or gum issues?
Have you *not* had radiotherapy to your head or neck in the past?
Are you able to attend all necessary dental appointments before your chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo the 'PRIOR' dental care plan before starting your chemotherapy. This involves a thorough check-up by a dental specialist to identify any existing dental problems like gum disease, cavities, or infections. You would then receive treatment for these issues, all within the relatively short timeframe before your planned chemotherapy begins. The study will monitor if this dental intervention impacts complications related to your chemotherapy. The exact number of visits will depend on your individual dental needs, but you must be able to attend all necessary appointments before your chemotherapy starts. The total duration of your active participation in this specific part of the study would be until you begin your chemotherapy.

Potential risks and benefits

Taking part in this study could potentially benefit you by improving your oral health before chemotherapy, which might reduce your risk of painful mouth sores and serious infections during your treatment. While the dental treatments themselves carry standard, low risks (like those associated with routine dental procedures), the overall aim is to make your chemotherapy journey safer and more comfortable. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Dental Translational & Clinical Research Unit (DenTCRU)
Verified postcode
Leeds, United Kingdom

Common questions

What is 'PRIOR'?

PRIOR stands for Proactive Intensive Oral Review & Treatment. It's a special dental care plan designed to check and treat any mouth problems before you start chemotherapy.

Why is dental health important before chemotherapy?

Chemotherapy can make your mouth more prone to infections and painful sores. Fixing dental problems beforehand aims to reduce these side effects and make your treatment smoother.

Will this study affect my cancer treatment?

No, the aim of this dental intervention is to help reduce complications, not to change your planned chemotherapy dose or schedule. It happens *before* your chemotherapy begins.

Do I have to pay for the dental treatment?

This study is part of NHS research, so any dental care directly related to your participation in the study would be covered.

What happens if I change my mind?

You are completely free to withdraw from the study at any point, and your decision will not affect your medical care.

How to find out more

Sue H Pavitt, PhD

s.pavitt@leeds.ac.uk +44 7939 014 659 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.