Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study of 5-ALA in bowel cancer surgery (GLISTEN)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a substance called 5-ALA which can show if bowel cancer has spread into your lymph nodes.
The most common place that bowel cancer spreads to is the
In this study, researchers are using a substance called 5-ALA which can make cancer cells glow red under a blue light. You have 5-ALA as a drink a few hours before your operation. You then have your surgery as planned. The people taking part in this study are having keyhole surgery to remove bowel cancer.
The aim of the study is to find the best dose of 5-ALA to use. The best dose will be the lowest dose that makes bowel cancer and any spread to the lymph nodes glow under the blue light during surgery.
Who can enter
You may be able to enter this trial if you
- Have been diagnosed with cancer that is in the part of your bowel called the right (ascending) colon or in the sigmoid colon
- Are going to have keyhole surgery to remove your cancer
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception from when you join the study until 30 days after having 5-ALA if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer in the parts of your bowel called the transverse or descending colon
- Have any other bowel problems (apart from cancer) such as inflammatory bowel disease
- Have liver or kidney problems
- Have had a bad reaction to a similar drug in the past, or can’t have 5-ALA for some reason
- Have had another experimental drug in the last 4 weeks
- Have any other medical condition or mental health problem that the study team think could affect you taking part
- Are pregnant or breastfeeding
This study will recruit about 50 people. Everybody taking part has 5-ALA a few hours before surgery. You have it as a drink which tastes slightly acidic - similar to lemon juice diluted in water.
During your operation, the surgeon will shine a blue (ultra violet) light from the camera they are using for keyhole surgery. The 5-ALA can make cancer cells in the bowel and lymph nodes glow red under this light. Your surgeon will then remove the bowel cancer and lymph nodes. The tissue removed will be examined in the laboratory by a
Taking part in the study does not change the surgery you have and your surgeon will not remove any extra tissue. But when the pathologist checks to see if there are cancer cells in your lymph nodes, they can also check whether these glowed red during the operation.
5-ALA has been used in other types of cancer and the first few people taking part in this study have the dose that is currently licensed. Depending on how well this shows bowel cancer cells, the second group will have either a higher or a lower dose. A third group of people will have whichever dose works best to confirm how well it can detect bowel cancer and spread to the lymph nodes.
Once the researchers find the best dose of 5-ALA, they will look at it in a larger study that will involve about 300 people.
Taking part in this trial does not change your treatment or follow up care, so there will not be any extra hospital visits or tests.
The side effects of 5-ALA include
- Feeling or being sick
- A fast heart rate for a couple of days
5-ALA can make your skin more sensitive to bright light. This means you should stay away from bright lights or sunlight for up to 48 hours after having it. Being in the hospital ward will not be a problem. During surgery, your eyes and skin will be protected from the operating lights.
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.
Professor David Jayne
NIHR Clinical Research Network: Cancer
NIHR Efficacy and Mechanism Evaluation (EME) Programme
St James's University Hospital
University of Leeds