One of the treatments for prostate cancer is radiotherapy. Whilst this can help to treat the cancer, it can lead to gastrointestinal complications such as diarrhoea, discomfort, more frequent urination and bleeding. Approximately 1 in 2 men can suffer from these side effects. Side-effects can remain for some time once treatment is completed which leads to further complications and affect quality of life.
There is evidence that a dietary fibre supplement may help with some radiotherapy side effects. In the DIETRICH study, we want to investigate if men who have their diet supplemented with a dietary fibre source called inulin before radiotherapy starts, during treatment and for a short time after, have fewer gut-associated side effects than those who do not take extra fibre.
We are recruiting up to 220 adult men in the UK who are due to get radiotherapy treatment (over 4 weeks) for their prostrate cancer.
Please see "Where can I take part?" to check if your local hospital is participating.
If you would like to know more about DIETRICH, including information about taking part, please email the DIETRICH study office at the University of Aberdeen: DIETRICH@abdn.ac.uk
There is also a link below to the DIETRICH patient information leaflet.
To find out if inulin reduces the side effects of radiotherapy on the bowel and bladder we are comparing the effects of inulin against the effects of a placebo ‘dummy treatment’, which looks and tastes the same as inulin but contains no active ingredient (in this case fibre). The placebo is called maltodextrin and is also a dietary supplement.
To try to make sure the Inulin and placebo groups are the same to start with, each person is put into a group selected by chance (randomly by a computer).
Half of the 220 people will take inulin and half will take maltodextrin for a total of 9 weeks (as well as any usual medicines). To make sure that the true effects of inulin are being studied the participant or the doctor will not know which treatment group they are in (although, if the doctor needs to find out they can do so).
During the 16 weeks participants will complete some questionnaires about their symptoms and some food diaries. You will have the choice if you want to complete these on paper or electronically (usually via a link that is sent by email so they can be completed via a computer or smart phone). Questionnaires on diet and symptoms would be completed before radiotherapy starts, the day radiotherapy begins and then again at weeks 4, 6, 10 and 16.
As with any research, you may not benefit personally from taking part. If you are randomised to the inulin, you may have fewer gut side effects, but we do not know this for sure. This is why we are doing the study. This trial will give us detailed information about quality of life and side effects, based on what participants tell us. We will also have information on how inulin affects bacteria in the gut and the beneficial chemicals they produce. The study will show how the gut environment varies between patients and whether their usual diet affects the gut environment. Results from this current project will allow us to apply for money to move quickly to a trial across the UK which could change clinical practice.
We do not think there are any major disadvantages for you. Inulin may cause nausea, bloating or flatulence however eating under 40g per day is considered safe and participants in DIETRICH will have 16g per day. Before you agree to take part in the study, you can and should discuss any concerns that you may have with your doctor.
Funding acknowledgement
This work was supported by Prostate Cancer UK through a Research Innovation Award Stage 2 Grant (RIA23-ST2-006).
Participant Information
University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 10 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information here :
https://www.abdn.ac.uk/about/privacy/research-participants-938.php or by contacting the Data Protection office at dpa@abdn.ac.uk