CompletedPhase I/IIInterventional

A trial of the synthetic cannabinoid ART27.13 to stimulate appetite in patients with cancer anorexia and weight loss

Many people living with cancer experience a loss of appetite, known as anorexia, which can lead to unintentional weight loss and weakness. This study is testing an experimental drug called ART27.13, a type of synthetic cannabinoid made in a laboratory. Researchers want to see if ART27.13 can safely boost appetite, help people gain healthy weight, and rebuild lean muscle. Currently, there are no approved medicines specifically for cancer-related appetite loss. The trial is open to adults with cancer who have lost more than 5% of their body weight in the last six months and are either taking a break from cancer treatment or are on certain stable therapies. Taking part lasts up to 18 weeks and involves hospital visits, blood tests, body scans, and questionnaires. The aim is to find out if this treatment is safe and effective.

At a glance

Status

Completed

Phase

Phase I/II

Sponsor

Artelo Biosciences Ltd.

Enrolment target

Start

23 Mar 2021

Estimated completion

30 Jul 2026

Cancer patients with anorexia and weight loss

What is this study about?

When you have cancer, or when you are going through treatments like chemotherapy or radiotherapy, it is very common to lose your appetite. This loss of appetite is called cancer anorexia. Over time, eating less can cause you to lose weight and muscle mass, leaving you feeling tired, weak, and less able to cope with your daily activities or cancer care. Doctors know that losing even a small amount of weight can affect how well you recover, but right now, there are no approved medicines specifically designed to help cancer patients regain their appetite.

This study, called the CAReS trial, is testing a new medicine called ART27.13. It is a synthetic cannabinoid, which means it is a laboratory-made compound designed to work on the body's natural appetite systems. The main goals of the study are to check that ART27.13 is safe, find the best dose to give, and see whether it helps patients feel hungrier, eat better, and regain muscle.

By taking part, participants help doctors learn whether ART27.13 could become an effective treatment for cancer-related weight loss in the future. Better appetite and nutrition can make a big difference to how people feel during their illness, helping to improve general strength and overall quality of life.

Key takeaways

Tests whether the drug ART27.13 can safely boost appetite and rebuild muscle in people with cancer.
Open to adults with cancer who have lost more than 5% of their body weight in the last six months.
Participation lasts up to 18 weeks and includes hospital visits, blood tests, and muscle scans.
Your safety is closely monitored throughout, and you can withdraw from the study at any time.
Taking part could help improve future care for cancer-related weight loss.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with cancer and have experienced unintentional weight loss. To qualify, you must have lost more than 5% of your normal body weight over the past six months and noticed a clear drop in your appetite or interest in food.

You may be eligible if you are currently not receiving cancer treatments and do not plan to start any in the next 12 weeks. You may also join if you have been on a stable daily dose of certain long-term therapies—such as hormone treatment for breast, prostate, or uterine cancer, or capecitabine for breast or bowel cancer—and will stay on that treatment during the study.

To ensure it is safe for you to take part, your liver, kidneys, and blood counts must be working reasonably well, and you must feel well enough to carry out daily tasks. Both men and women taking part must agree to use reliable contraception during the trial and for six months afterwards.

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 am aged 18 or older.
I have a confirmed cancer diagnosis.
I have lost more than 5% of my body weight without trying to in the last 6 months.
I have noticed a significant drop in my appetite or an aversion to food.
I am not on active chemotherapy, or I am on a stable daily hormone tablet or capecitabine.
I am able and willing to travel to hospital appointments over an 18-week period.

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will last up to 18 weeks. You will need to attend several clinic visits at a participating NHS hospital or specialist centre. During these visits, doctors and nurses will monitor your health closely through routine physical exams, checks of your blood pressure and heart rate, heart tracings (ECGs), and regular blood tests. You will also have special low-dose X-ray scans, called DEXA scans, which measure how much muscle and body fat you have.

Throughout the study, you will take the study medicine as directed by the clinical team. You will also be asked to fill out short questionnaires about your appetite, how you are feeling, and your daily quality of life, as well as keep a simple diary if you take steroid medications. The trial team will guide you through each step and answer any questions you have along the way.

Potential risks and benefits

We cannot guarantee that taking ART27.13 will directly improve your appetite or help you gain weight, although early evidence suggests it might. The information gathered may also help doctors treat appetite loss in future cancer patients. As with any new medicine, there is a chance of experiencing side effects or discomfort from routine tests like blood draws. Your medical team will monitor you very closely at every visit to manage any issues. Joining the study is completely voluntary, and you are free to leave at any time without it affecting your standard NHS care.

Locations (10)

Western General Hospital
Approximate
Edinburgh, Scotland
The Royal Marsden Hospital (london)
Approximate
London, England
The Royal Marsden Hospital (surrey)
City only
Sutton, England
St James's University Hospital
Approximate
Leeds, England
The Christie
Approximate
Manchester, England
The VCTC
Unverified
Castle Donington, England
The VCTC
Unverified
Oxford, England
The VCTC
Unverified
Wellingborough, England
University Hospital Hairmyres
Unverified
East Kilbride, Scotland
St James Hospital
Unverified
Dublin, Ireland

Common questions

What is a synthetic cannabinoid?

It is a man-made chemical created in a laboratory that acts on specific receptors in the body to help stimulate hunger, without using natural cannabis.

Will taking part interfere with my current cancer treatment?

Only patients who are either taking a break from cancer treatment or are on specific, stable daily therapies can join. The study doctors will carefully check if your current treatment plan is suitable.

How often will I need to visit the hospital?

You will need to attend a series of clinic visits over an 18-week period. The study team will provide a clear schedule so you know exactly when each visit takes place.

Can I leave the study if I change my mind?

Yes. Taking part is entirely your choice. You can withdraw at any time, for any reason, and your regular NHS medical care will continue as normal.

Where is the trial taking place?

The study is running at several major NHS hospitals and specialist centres across the UK, including London, Edinburgh, Leeds, Manchester, Derby, and Glasgow, as well as Dublin.

How to find out more

Barry J A Laird

Barry.laird@ed.ac.uk - Official trial record

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