About the trial - for Patients and Public

Some lung cancers respond well to treatments that target the genetic changes that drive cancer growth. However, that approach does not work in Squamous cell lung cancer (LUSC), so different approaches are urgently needed. 

There has always been interest in whether dietary changes can affect cancer but it is likely that only certain cancers will respond to changes in diet. We believe that LUSC is a prime candidate, as it takes up high levels of glucose from the bloodstream to fuel its growth and protect itself from damaging substances known as ‘reactive oxygen species’ (ROS). 

One way of reducing glucose availability is to follow a ketogenic diet therapy, a very low carbohydrate, high fat, moderate protein diet. The low carbohydrate intake causes the body to convert fats into ketones to use as an additional source of energy. 

When diagnosed, patients receive standard treatment, which involves a combination of chemotherapy and immunotherapy. The KETO-Lung trial will recruit patients with Squamous cell lung cancer (LUSC) to find out whether adding a Ketogenic Diet Therapy (KDT) to the standard chemotherapy/immunotherapy treatment improves how long patients live, delays the growth of their tumour and/or improves their quality of life.

A ketogenic diet is a very low carbohydrate, high fat, moderate protein diet. It controls blood glucose levels, reduces insulin levels and shifts the body’s metabolism away from carbohydrates and toward fat and ketones. Ketogenic meals are based on regular food ingredients; meats, fish, eggs, nuts, seeds, cheese, vegetable oils, butter, cream, low carbohydrate vegetables (e.g. broccoli, kale, salad vegetables) and fruits (e.g. berries). Regular breakfast cereals; bread, rice, pasta and sugar are not included, but there are many ketogenic alternatives. 

For more information on medical ketogenic diet therapy we recommend matthewsfriends.org.

This is a phase II single arm trial. This means that for those who enter the trial, everyone receives the same treatment. 

In this trial, each 21-day (3 week) period is called a “cycle” of treatment. For 4 cycles totalling 12 weeks, you will receive treatment of chemotherapy (paclitaxel and carboplatin) and immunotherapy (pembrolizumab) which is standard care. You will have to follow a continuous KDT throughout this time, and for one week before starting the trial.  At the end of cycle 4, you will receive pembrolizumab immunotherapy for 3-weeks as standard care.

Patients will undergo screening assessments to ensure that it is appropriate and safe for them to take part. Once eligibility is confirmed, patients will be registered to take part in the trial. Once registered into the trial, patients will receive a personalised KDT along with standard chemotherapy/immunotherapy for 4 cycles (each 3 weeks long). 

During trial treatment, patients will need to attend clinic appointments every 3 weeks for scheduled visits whilst receiving treatment so that their progress can be assessed. They will also need to be regularly reviewed by a trial dietitian while on the trial. You will need to see the dietitian in person every 3 weeks (at the start of each cycle) whilst having treatment, so they can assess your progress with the KDT. This will be on the same day as your clinic appointment. On the other weeks (1, 2, 4, 5, 7, 8, 11 and 12) you will have either a telephone or video-call appointments with your dietitian to discuss how you are getting on with the trial. 

After patients stop trial treatment, they will continue to be followed up for at least 12 months to see how the trial affected their health. 

The diagram below shows a summary of the KETO-Lung trial (view accessible version):

The KETO-Lung trial is investigating whether LUSC could respond to dietary change using a ketogenic diet as therapy (KDT), enabling both chemotherapy and immunotherapy to work more effectively, hopefully improving current outcomes. 

It will also assess how patients feel on the treatment and how it affects their quality of life.

The trial is aiming to recruit 48 patients with Squamous cell lung cancer (LUSC) from across the UK over a period of 18 months.

The trial will be open to any adult (aged over 16 years) with Squamous cell lung cancer (LUSC).

There are additional inclusion and exclusion criteria for the trial which your treating doctor should be able to discuss with you.

If you think you would be eligible to enter the trial, then you should first talk to your oncologist at your next hospital visit about how to be involved. 

If you are not being treated at one of the primary recruitment centres and are interested in the trial, please discuss it with your consultant. You may still be able to be involved; however, you will need to be able to travel to one of the participating centres. 

Please note that the staff at the KETO-Lung Trial Office are not able to directly recruit you onto the study.

The trial will be opened at 7 NHS hospitals across the UK.

The trial is currently open at:

• Freeman Hospital, Newcastle

The following hospitals are planning to open in the future:

Queen Elizabeth Hospital, Birmingham
Addenbrooke's Hospital, Cambridge
Beatson West of Scotland Cancer Centre, Glasgow
The Christie, Manchester
Southampton General Hospital, Southampton
Weston Park Hopsital, Sheffield  

If your local hospital is not listed here, please speak to your doctor who may be able to refer you to a participating hospital if you both feel this is suitable for you.

Involving members of the public in designing and running clinical trials, and related projects, is very important. Not only does it help us ensure the best interests of patients are always at the forefront of researchers’ minds, but it provides valuable insights into patients’ experiences that help to shape our research. 

Our Trial Management Group benefits greatly from patient representation with the involvement of Janette Rawlinson, a previous lung cancer patient. Janette is an integral part of the trial as a co-applicant. Her role has included regularly attending meetings from the outset and being involved in the development of our patient information documents and consent procedures. 

Similarly, there is a patient representative on our Trial Steering Committee to help bring a patient perspective to these meetings. 

If you are a member of the public and would like to be involved in KETO-Lung, please get in touch with the KETO-Lung Trial Office.