PanDA: Pancreatic cancer Dietary Assessment Study
Research title: Prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with inoperable pancreatic malignancies
Why is this study being carried out?
The pancreas plays an important role in digesting food, as it produces enzymes that help to break down food. Pancreatic cancer can reduce the number of enzymes that your pancreas makes. It can also block the enzymes from getting to the bowel, where they are needed for digestion. This means that food is not digested properly.
Problems digesting food can cause a wide range of symptoms, including:
- weight loss
- changes to your bowel habits
- feeling and being sick
- extreme tiredness
- loss of appetite
- and feeling full quickly when eating.
These symptoms can be treated with pancreatic enzyme supplements; which include Creon®, Pancrease®, Nutrizym® and Pancrex®. You should be told about pancreatic enzyme supplements by your doctor, nurse or dietitian. If you think you have these symptoms, ask about enzyme supplements.
The PanDA study will look into the problems with digestion that people with pancreatic cancer may have, and find out how common these problems are. The study will also find out if talking to a dietitian can improve how symptoms linked to diet are diagnosed and managed with pancreatic enzyme supplements. A dietitian is a health professional that provides expert advice about diet and nutrition. The PanDA study hopes to create a better way to diagnose problems with digestion in the future.
This study is only taking place at The Christie, which is a hospital in Manchester.
Finding ways to manage your dietary symptoms can help you feel better generally. If you can’t take part in this study and haven’t seen a dietitian, and you are having problems with your diet and eating, or are losing weight, ask your medical team or GP to refer you to a specialist dietitian.
What does this trial involve?
If you take part in the PanDA study at The Christie, your doctor will put you into one of two groups.
- One group will have just one appointment.
- One group will have two appointments. The second appointment will take place two weeks after the first appointment.
In the first appointment, the dietitian will measure your weight. You will be asked to do some tests to see how fit you are, for example, walking up some stairs. You will also be asked to complete a short questionnaire about your appetite.
This appointment will take place during your routine hospital visit, and it should take no longer than an hour.
You may need to have a blood test taken in this appointment. This can tell the dietitian more about your digestion. If you need further support from a dietitian, this will be available outside of this study.
If you are part of the second group of the PanDA study, you will have another appointment two weeks after the first one. The aim of the second appointment is to test how well your pancreas is working, and how well your food is being digested.
Before this appointment, you will be asked to collect a small sample of your poo at home to bring to the appointment. Your dietitian will give you instructions on how to do this.
During the appointment you will also have a breath test. The appointment will begin in the morning, as you won’t be able to have any food or drinks for 10 hours before the breath test begins. There are some specific foods that you will need to avoid for two days before the breath test. If you have been diagnosed with diabetes, discuss this with your dietitian first.
When you arrive at the appointment you will take a tablet called metoclopramide, which will speed up your digestion. Metroclopramide is a common medicine that is used to help with feeling or being sick (nausea and vomiting). You will then be given a snack to eat before the test begins, and half a pint of water to drink. You can drink this water straight away, or save it to drink during the test. You won’t be able to have any other food or drink during the test.
The breath test takes 6 hours to complete, so you will need to stay in the hospital during the day. You will gently blow into a small container every 30 minutes, so that small samples of your breath can be collected. You will be able to eat and drink again after the test is finished. And you won’t need to have any further tests for this study.
It will take two weeks to get the results of the poo sample and breath tests. The dietitian will get in touch with you to talk about these results, and whether your diet or treatment needs to be changed to help you feel better.
Who is the study suitable for?
- you have been diagnosed with, or have suspected pancreatic cancer – this may be pancreatic ductal adenocarcinoma (PDAC) or a pancreatic neuroendrocrine tumour (PanNET)
- you are receiving care at The Christie, a hospital in Manchester
- you can not have surgery to remove your cancer (inoperable cancer)
- your medical team at The Christie have discussed the possibility of having chemotherapy with you
- you are well enough to take part in this study – your doctor can speak to you about this.
- you have had surgery to remove your cancer
- you can’t eat food that contains gluten
- you are at risk of digestion problems due to other conditions, such as chronic pancreatitis, cystic fibrosis, inflammatory bowel disease, or diabetes that was diagnosed more than 5 years ago.
There may be other reasons for not being able to take part in a study. It is important to speak to your doctor about whether this study might be suitable for you.
Recruitment start date: June 2018
Recruitment end date: June 2020
The PanDA trial is being carried out at The Christie NHS Foundation Trust, Manchester.
Professor Juan Valle
You can contact the trial centre by emailing Lindsay Carnie, Specialist Research Dietitian, at email@example.com
How to join the trial
To take part in this study you must be receiving care at The Christie NHS Foundation Trust, Manchester. Speak to your consultant about whether this study is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial go to the ClinicalTrials.gov website.
If you would like the references for information used to develop this information, email us.