A trial looking at personalised ketogenic diet therapy with the standard treatment for lung cancer (KETO-Lung)
Cancer type:
Status:
Phase:
This trial is looking at whether a personalised ketogenic diet therapy can improve the outcome of 
for lung cancer.
It is open to people with a lung cancer that has spread.
More about this trial
Squamous cell lung cancer is a type of non small cell lung cancer (NSCLC). The standard treatment for this type of NSCLC is a combination of and an . A combination that doctors use is:
- paclitaxel and carboplatin – chemotherapy
- pembrolizumab – immunotherapy
We know that squamous cell lung cancer takes glucose (a sugar) from the blood to help it grow and protect itself. Researchers think that by lowering the amount of glucose available to cancer cells might improve the outcome of treatment.
You can lower the levels of glucose in the blood by following a ketogenic diet. A ketogenic diet is a very low , high fat, moderate protein diet.
When you follow a ketogenic diet your body breaks down fat into ketones to use as energy instead of carbohydrates. This is called ketosis. The level of ketosis can be measured by looking at substances (biomarkers) in the blood. For ketosis doctors look at the level of glucose in the blood in relation to the level of ketones in the blood. This is the ratio of glucose to ketone. The biomarker for ketosis is called the Glucose Ketone Index (GKI).
shows that combining a ketogenic diet with a combination of chemotherapy and immunotherapy can be better than chemotherapy and immunotherapy by itself.
To find out whether following a ketogenic diet can improve treatment, researchers need to do a large . Before doing a clinical trial, they need to find out whether people are willing to follow a ketogenic diet. To find this out they do a .
In this feasibility study, everyone will follow a ketogenic diet therapy while having the standard treatment.
The aims of the feasibility study are to find out:
- whether a certain level of ketosis can be maintained
- how acceptable a ketogenic diet is for people
- how well people tolerate it
- how this diet affects people’s
quality of life - how well the standard treatment and the diet works
- whether the diet affects the side effects of treatment
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:
- have a non small cell lung cancer that is a squamous cell cancer that has spread into the surrounding tissue or to another part of the body and you are able to have carboplatin, paclitaxel and pembrolizumab
- are willing to change your diet for 13 weeks
- are willing to monitor your blood glucose and ketones levels at home daily and have a weekly discussion with a member of the trial team about the levels
- are able to look after yourself and are active but might not be able to do heavy physical work (performance status 0 or 1)
- have an area of cancer that the doctor can measure
- are willing to have blood samples and samples of tissue (
biopsies ) taken for testing - have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a time after if there is any chance you or your partner could become pregnant
- are at least 16 years old
Who can’t take part
Cancer related
You cannot join this trial if either of these apply. You:
- have cancer that has spread to the brain or the tissue surrounding the brain that is causing symptoms and has not been treated
- had another cancer in the past 3 years. This is apart from
non melanoma skin cancer and any carcinoma in situ (CIS) .
Medical conditions
You cannot join if any of these apply. You:
- have an
autoimmune disease apart from those affecting the thyroid gland that is well controlled - need to have a high
carbohydrate diet because of a medical condition - have a
digestive system problem that could affect you taking part. Your doctor will know about this. - are taking more than 10mg of steroids a day regularly
- have or had loss of appetite
- are taking medication for
diabetes . You might be able to take part if you have type 2 diabetes and the medication can be adjusted. Your doctor will know about this. - have an
inherited condition, called familial hyperlipidaemia, where your liver cannot process fats properly - have, or had, inflammation of the
pancreas - have recently had kidney problems,
heart problems , liver problems , lung problems or problems with any other part of the body. Your doctor will ask about these and tell you if you are able to take part. - have symptoms of a
superior vena cava blockage - have a medical condition where the nutrients from your diet cannot reach the cells of the body
- have had your
gallbladder removed - have problems with your bones such as osteoporosis
- have HIV, active hepatitis B or hepatitis C
- had tuberculosis (TB) or have any other infection that needs treatment
- have had an organ transplant or transplant using donor stem cells (an
allogeneic stem cell transplant ) - have any other medical condition, mental health condition or other circumstances that could affect you taking part
Other
You cannot join if any of these apply. You:
- are not able to go without food for periods of time (fasting)
- are not able to have the treatments in this trial
- are not able to follow the ketogenic diet
- are pregnant or breastfeeding
Trial design
This phase 2 trial is a feasibility study. The team need about 48 people to take part.
Everyone has the standard treatment of chemotherapy with an immunotherapy and personalised ketogenic diet therapy.
Standard treatment
The standard treatment is:
- paclitaxel and carboplatin with
- pembrolizumab
You have treatment every 3 weeks. Each 3 week period is a . You have 4 cycles. You have the treatment as a drip into a vein.
Ketogenic diet therapy
You have an introduction week of the ketogenic diet therapy before starting treatment. You then continue with the diet for the 4 cycles of the standard treatment. This is a total of 13 weeks.
You see a before starting the diet. They will explain the diet and will give you a personalised diet to follow based on your current diet and what foods you like. You continue to see the dietitian at the start of each cycle of the standard treatment. This is to see how you are going with the diet. This appointment is on the same day as your clinic appointment before you have treatment. On the weeks between treatment, the dietitian will call you or have a video call to see how you are.
You or someone else will need to prepare and cook the food for the diet. The dietitian will give you suitable recipes that are easy and simple to follow.
When you start, the dietitian will give you some ketogenic products to help you get started. These will be shakes and yoghurts that you can take with the ketogenic diet therapy. You will also have recipe books and a starter pack with weighing scales and other useful items to help you start your diet.
Tests you do at home
The team need to keep a check on the level of ketones and glucose in your blood. You measure your glucose levels using a Freestyle Libre device that people with diabetes regularly use. The team will tell you more about the device and what you need to do.
You will also measure your ketone levels twice a day, for this you do a finger-prick blood test. They will give you the equipment to do this and will train you on how to use it.
Diary
You have a diary to record what you eat and drink each day. You also write down any side effects you have. You need to hand in the diary at every clinic appointment. You will get another diary at each appointment.
Quality of life
You fill in questionnaires:
- before starting treatment and then
- at the start of each cycle of treatment
The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- any symptoms or side effects
These are quality of life questionnaires.
Patient card
The team gives you a card that has information about the trial and who to contact in an emergency. You should carry this card with you at all times and give it to the doctor if you go into hospital.
Samples for research
The team take extra blood samples. Where possible they will take these when you have blood tests as part of your routine care.
They will ask for a poo sample:
- before starting treatment and then
- on 2 different occasions while on treatment
Metabolic Sub Study
This is to assess whether the ketogenic diet has changed how the body uses glucose and ketones. You have a blood sample taken before starting treatment.
At week 5 of treatment, you have a drip () of glucose. Two hours after the infusion the team take:
- blood samples
- a sample of tissue (
biopsy ) from the cancer
You doctor will tell you more about the sub study when they tell you about the trial.
Interviews
The team will ask 10 people to take part in an interview. The team will do the interview after the trial is finished. It will take place over the phone or as a video call.
A separate information sheet and will be sent out to you if you are interested in taking part and are selected for an interview.
Hospital visits
You see the doctor for a and tests before taking part. The tests include:
- blood tests
- a CT scan or an MRI scan, your doctor will tell you which one you will have
You see the doctor and the dietitian regularly during treatment. This is to:
- see how you are
- have blood tests
- ask how you are going with the ketogenic diet
After stopping the ketogenic diet
You see the doctor at:
- week 12
- week 15
- week 18
This is to see how you are and for tests.
As part of the trial, you then see the doctor every:
- 4 weeks for 6 months and then
- 12 weeks for up to a year
Side effects
The trial team 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.
Your doctor will talk to you about the possible effects that might happen when you change to the ketogenic diet. They will also tell you about the possible side effects of the standard treatment. You will be able to ask any questions you might have before you agree to join the trial.
When you make a significant change to your diet, your body needs to adjust. The ketogenic diet changes what the body uses for fuel. Instead of getting it from carbohydrates the body gets it from the body’s own fat. This can cause some effects.
Another study that looked at using a ketogenic diet for people with cancer found that the side the effects included:
- low amounts of salt in the blood
- low amounts of calcium in the blood
- constipation or diarrhoea
- feeling sick
- headache
- not being able to think clearly (brain fog)
- difficulty sleeping
- feeling irritable
- leg cramps
- bad breath
- feeling tired
- weight changes
- low amounts of potassium in the blood
- low blood pressure
- kidney stones
- not having enough fluid in the body (dehydration)
- high amount of cholesterol in the blood
- low amount of sugar in the blood
- high amounts of ketones in the blood
Between 2 and 7 days after starting the ketogenic diet you might have keto-flu. The signs of keto-flu include:
- headache
- brain fog
- tiredness
- feeling irritable
- feeling sick
- difficulty sleeping
- constipation
|
Pembrolizumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
We have information about the side effects of:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Gary Middleton
Supported by
Cancer Research UK
Birmingham Cancer Research UK Clinical Trials Unit
University of Birmingham
Other information
This is Cancer Research UK trial number CRUK/22/014.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
