RecruitingInterventional

A clinical trial assessing the addition of continuous ketogenic diet therapy to standard chemotherapy and immunotherapy treatment for patients with advanced squamous cell lung cancer

Squamous cell lung cancer is a common lung cancer that uses a lot of sugar (glucose) from the blood to grow and protect itself. Standard NHS treatment uses a combination of chemotherapy and immunotherapy to attack the cancer and support the body's immune system. The KETO-Lung trial is testing whether changing your diet can make these standard treatments more effective. Participants follow a strict ketogenic diet—which is very low in carbohydrates and high in fats—for about 13 weeks alongside their usual cancer drugs. When you cut carbohydrates, your body turns fats into energy sources called ketones. Early laboratory research shows that this switch may leave cancer cells vulnerable and help immunotherapy fight them more effectively. This study aims to find out if this dietary approach is safe, doable, and beneficial for patients.

At a glance

Status

Recruiting

Sponsor

University of Birmingham

Enrolment target

Start

27 Nov 2024

Estimated completion

30 Nov 2027

Lung cancer

What is this study about?

Squamous cell lung cancer is a serious type of lung cancer affecting thousands of people in the UK each year. Unlike some other forms of lung cancer, it does not respond well to targeted genetic tablets. The usual first choice of treatment is a combination of chemotherapy and immunotherapy. Chemotherapy works by directly damaging cancer cells, while immunotherapy helps your own immune system find and attack them.

Doctors have long wondered if changing what we eat could help fight cancer. Cancer cells often depend heavily on glucose (sugar) from food to grow and shield themselves from damage. Squamous cell lung cancer is especially reliant on sugar. When sugar levels drop, these cancer cells find it harder to defend themselves against chemotherapy.

In this study, researchers are asking patients to follow a ketogenic diet. This is a medical eating plan that is very low in carbohydrates (such as bread, pasta, and sugar) and high in fats. This diet causes the liver to break down fat into molecules called ketones, which the body uses for fuel instead of sugar. Early tests suggest that ketones may also help immunotherapy drugs work more powerfully.

By testing this diet in a well-organised clinical trial, researchers hope to discover whether cutting out sugar can genuinely improve treatment outcomes. If successful, this trial could offer a new, low-cost way to support standard NHS cancer care in the future.

Key takeaways

Tests whether a high-fat, very low-carbohydrate diet helps standard lung cancer treatments work better.
Open to people aged 16 and over with advanced squamous cell lung cancer starting their first treatment.
Involves following a ketogenic diet for about 13 weeks alongside standard chemotherapy and immunotherapy.
Requires daily at-home finger-prick testing and a tumour biopsy at week five.
You will receive dedicated dietary support and can leave the trial at any time without affecting your NHS care.

Who may be eligible?

This trial is open to people aged 16 and older who have been diagnosed with advanced or metastatic squamous cell lung cancer. It is designed for patients who are about to start their very first round of standard chemotherapy and immunotherapy (using the medicines paclitaxel, carboplatin, and pembrolizumab).

To take part, you need to be well enough to carry out daily activities and look after yourself. You must be willing to follow the strict ketogenic diet for around 13 weeks, which includes a one-week warm-up period. You will also need to be comfortable testing your own blood sugar and ketone levels each day at home using a simple finger-prick test, and talking through your readings with the study team each week.

Because the study looks closely at how the body processes food and medicines, you must be willing to have regular blood tests and a small tissue sample (biopsy) taken from the tumour during week five. You will also need satisfactory kidney, liver, and blood test results, and participants who could become pregnant or father a child must agree to use reliable contraception.

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.

I have been diagnosed with advanced or metastatic squamous cell lung cancer.
I am aged 16 or older.
I am preparing to start first-line chemotherapy and immunotherapy.
I feel well enough to manage my daily self-care and light activities.
I am willing and able to follow a strict low-carbohydrate diet for 13 weeks.
I am comfortable doing daily finger-prick blood checks at home.

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you will take part for around 13 weeks in total. This includes a one-week preparation phase to help you get used to the diet, followed by 12 weeks on the continuous ketogenic eating plan. Throughout this time, you will receive your standard chemotherapy and immunotherapy through a drip at the hospital, usually once every three weeks.

At home, you will do daily finger-prick tests to check your blood sugar and ketone levels and keep a record of your numbers. You will have regular weekly contact with the trial team, including specialist dietitians who will guide you on what to eat. You will also attend hospital visits for your routine cancer care, standard scans, regular safety blood tests, and a planned tumour biopsy around week five to see how the cancer is responding. After the 12 weeks of diet therapy finish, your medical team will continue to monitor your health and follow up on your progress.

Potential risks and benefits

Taking part may or may not help you personally, as researchers do not yet know if the ketogenic diet improves cancer treatment results. The information gained will, however, help doctors better understand cancer metabolism and improve care for future patients. Changing to a strict ketogenic diet can be challenging and may cause temporary side effects such as tiredness, nausea, digestive changes, or weight loss. Combining the diet with chemotherapy could also alter typical side effects. You are free to stop following the diet or leave the study at any point without giving a reason, and your regular NHS medical care will continue as normal.

Locations (7)

Queen Elizabeth Hospital
Approximate
Birmingham, England
Christie Hospital
Approximate
Manchester, England
Beatson West of Scotland Cancer Centre
City only
Glasgow, Scotland
Weston General Hospital
Approximate
Weston-super-mare, England
Freeman Hospital
Approximate
Newcastle upon Tyne, England
Southampton General Hospital
Unverified
Southampton, England
Velindre Cancer Centre
Unverified
Cardiff, Wales

Common questions

What exactly is a ketogenic diet?

It is an eating plan that drastically reduces carbohydrates (like bread, potatoes, rice, and sugary snacks) while increasing healthy fats. This shifts your body's main fuel source from sugar to fat-derived molecules called ketones.

Will I still get my normal cancer treatment?

Yes. You will receive the full, standard NHS chemotherapy and immunotherapy treatments alongside the special diet.

Will I get help planning what to eat?

Yes. Specialist dietitians work closely with you throughout the study to make sure your meals are balanced, safe, and fit the trial requirements.

How do I check my ketones and blood sugar?

You will be given a home testing kit that uses a quick finger-prick drop of blood, similar to monitors used by people with diabetes.

Can I leave the study if the diet is too hard?

Yes. Participation is entirely voluntary. You can stop the diet or leave the trial at any time, and your doctors will continue to give you the standard cancer care.

How to find out more

Joshua Savage

keto-lung@trials.bham.ac.uk +44 (0)121 415 8421 Official trial record

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