A study looking at how bacteria in the gut affects treatment for pelvic cancer (PELICAN-23)

Cancer type:

Bladder cancer

Bowel (colorectal) cancer

Cervical cancer

Colon cancer

Ovarian cancer

Prostate cancer

Rectal cancer

Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Other

This study is looking to see if gut bacteria (the microbiome Open a glossary item ) affects how well treatment works for certain cancers that start in the pelvis.

The pelvis Open a glossary item is the lower part of the tummy (abdomen) between the hips.

The study is for people having treatment at Aberdeen Royal Infirmary. And who have one of the following types of cancer:

More about this trial

You might have radiotherapy Open a glossary item , chemotherapy or surgery to treat bowel cancer and cancer that started in the pelvis. You might have a combination of these treatments.

The natural bacteria that live in your mouth and gut is the microbiome. There are lots of bacteria in our gut. We know that they are important for keeping us healthy. We also know from research into other cancers that bacteria normally living in our bowels change the way our body fights the cancer cells.

The researchers in this study are looking to see if this also happens in cancers that start in the pelvis or bowel. To do this they will look at:

poo samples
blood samples

They analyse the poo samples for the types of bacteria in them and how they might interact with your body.

The main aims of this study are to find out:

whether the gut microbiome can predict how well treatment works
if different types of cancer have different bacteria in the bowel and if these bacteria change how treatment works

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if you have one of the following types of cancer:

And all of the following must apply.

You are having treatment for your cancer at Aberdeen Royal Infirmary.
A sample of tissue biopsy confirmed your cancer type or you have not had a biopsy but your MDT agreed that it is highly likely you have a cancer in the pelvis and you are having treatment for this.
You are at least 16 years old.

Who can’t take part

You cannot join this study if you have another cancer.

Trial design

This study is taking place at the Aberdeen Royal Infirmary. The team need 450 people to take part.

Study samples
You give a poo sample before you start treatment or early on in your cancer treatment.

The team give you the kit to collect the poo sample at home. The kit includes instructions on how to collect the sample. You drop it off at the hospital at your next hospital visit.

If you have bowel cancer the team may ask to take some samples at the time of your operation. Your surgeon will collect these.

The team also ask to access a blood sample which you may already have had taken as part of your treatment. They plan to use some of the blood for this research. You don’t need to have any extra blood samples as part of this study.

Food questionnaires
There are 2 food questionnaires. The team ask you to choose one to complete. The first one is called a food frequency questionnaire. It asks you to give details of the types of foods you have had over the last 3 months. It also asks if you take any diet supplements. The questionnaire takes about 20 to 30 minutes to complete.

The second questionnaire is a food diary. This involves keeping a record of all the food you have over a period of 4 days. You complete it for 4 days before you give the poo sample. The diary asks you to give details of the foods you have and to estimate portion sizes.

You don’t have to complete these questionnaires if you don’t want to. It won’t affect you taking part in the rest of the study.

You return the questionnaires to the hospital when you have your next hospital visit.

Other information
The team will ask to collect information from your medical records. This includes:

any medications you take
the type of cancer you have
what cancer treatment you had
how your treatment worked

The team continue to access your medical records now and again. They do this for up to 5 years after your cancer treatment finishes. This allows the team to compare the results of your poo bacteria analysis with how your treatment worked.

Hospital visits

You might have an extra hospital visit if you join this study to sign the consent form Open a glossary item . Where possible the team do this during a routine hospital visit.

Side effects

There aren’t any side effects from taking part in this study.

Your doctor and nurses monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. We have information about: