A study to collect detailed information about side effects of radiotherapy for cancers of the prostate, head and neck or central nervous system (VoxTox)

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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Brain (and spinal cord) tumours

Head and neck cancers

Prostate cancer

Status:

Closed

Phase:

Other

This is a study looking in more detail at the side effects of radiotherapy for cancers of the prostate, head and neck and central nervous system.

The study is part of the VoxTox Research Programme which is funded by Cancer Research UK and brings together a wide range of doctors and scientists.

More about this trial

Doctors use radiotherapy to treat many types of cancer. Radiotherapy treatment is planned very carefully and techniques such as intensity modulated radiotherapy (IMRT) can shape radiation beams to treat the cancer, while avoiding surrounding healthy tissue. Although this makes it very precise, radiotherapy can still cause damage to some healthy tissue.

In prostate cancer this may be damage to the back passage (the rectum )
In head and neck cancer, it may be damage to the salivary glands
If you have radiotherapy for a brain tumour, areas of the brain called the hypothalamus and the pituitary gland may be damaged

In this study, researchers want to understand more about the side effects of radiotherapy and to work out how much radiation has reached healthy tissue.

Everybody taking part has a CT scan to plan their radiotherapy treatment. They also have a scan each time they have treatment to check they are in the correct position. This is called image guided radiotherapy. The study is taking place in Cambridge using a Tomotherapy machine which combines image guided radiotherapy with IMRT.

Taking part in this study does not change your treatment in any way. The information collected may help to reduce side effects for people who have radiotherapy in the future.

Who can enter

You may be able to enter this study if you

Have a cancerous or non cancerous (benign) tumour of the prostate gland, head and neck or central nervous system
Are going to have radiotherapy to try and cure your tumour
Are at least 18 years old

If you are having radiotherapy for a tumour in your central nervous system, the target area for radiotherapy must include part of your skull.

The study is also recruiting people who have already had radiotherapy using the Tomotherapy machine at Addenbrooke’s Hospital, Cambridge.

You cannot enter the study if you have had radiotherapy to the same area of your body in the past.

Trial design

The study is recruiting 2 groups of people.

One group (cohort) is for people who have already had radiotherapy. This is called discovery cohort and includes

About 350 people who have had treatment for head and neck cancer
About 500 men who have had treatment for prostate cancer
About 80 people who have had treatment for a tumour in the central nervous system

Doctors have already found enough people to join the discovery cohort. So this group is now closed.

The other group is for people who are going to have radiotherapy. This is the consolidation cohort and includes

About 400 people having treatment for head and neck cancer
About 800 men having treatment for prostate cancer - this is now closed
About 120 people having treatment for a tumour in the central nervous system

If you have already had radiotherapy for prostate cancer or head and neck cancer, you will have an interview with a researcher once a year for 5 years. The researcher will ask detailed questions about any side effects you have. If you had treatment for prostate cancer, this will include questions about your bowel, bladder and erectile function. If you had treatment for head and neck cancer, the questions will be about whether your mouth is dry and how easily you are able to swallow.

The researchers may also ask people who had head and neck cancer to fill out some questionnaires at home and post them back to the study team. These will ask about your quality of life. There will be up to 4 questionnaires over a 2 year period.

If you had radiotherapy for a tumour in your central nervous system, you will have a blood test every year as part of your routine follow up. This is to see if there are changes in the levels of hormones Open a glossary item that are produced by the hypothalamus and pituitary gland. If a blood test shows hormonal changes, or you have symptoms that suggest a change in your hormones, you will be referred to a specialist called an endocrinologist. The study team will get the results of your blood tests. They will also see if you are referred to an endocrinologist, and if so, look at the results of any further tests they arrange for you.

For everybody in the study, the researchers will look at

Your hospital notes
The CT scan you had before you started radiotherapy
Your radiotherapy treatment plan
The daily scans you had during treatment

The group who are going to have radiotherapy will have intensity modulated radiotherapy. Each time you have treatment, you have another CT scan on the Tomotherapy machine (image guided radiotherapy).

If you are having treatment for prostate cancer or head and neck cancer, the researchers will look more closely at the position of the surrounding healthy tissues on these daily scans. To do this, they may need to increase the number of images taken during the scan. This should not affect the overall length of your radiotherapy appointment.

The study team want to see if people having radiotherapy for a brain tumour have hormonal changes after treatment. You will have a blood test before starting treatment, 6 months later, 1year later and then once a year for the next 5 years. The study team will also ask you to have 4 more blood tests at your GP surgery between these visits.

Hospital visits

People in the group who have already had radiotherapy will not have any extra hospital visits, but your routine visits will be longer. The interviews you have with the researchers will take about half an hour. If you are unable to go to hospital, they may ask you to have the interview by phone.

People who are going to have radiotherapy for prostate cancer see the study team every 2 weeks during their treatment and until any side effects get better. After that, you see the study team after 3 months, 6 months and then once a year for 5 years. Each time, they will ask about side effects. They may ask you to fill in some questionnaires to help them understand more about the impact radiotherapy has on your quality of life.

People who are going to have radiotherapy for head and neck cancer see the study team every week during radiotherapy and then 4 weeks and 8 weeks after treatment to check that any side effects are improving. After that, you see them after 3 months, 6 months, 1 year and then once a year for 5 years. Each time, they will ask about side effects. They may ask you to fill in some quality of life questionnaires at home and post them back.

People who are going to have radiotherapy for a brain tumour will have 7 hospital visits over 5 years to check their hormone levels. Each visit will last about 5 hours. You must not eat or drink anything from midnight the night before. The study team will give you more information about the tests you will have at these visits.

Side effects

There are no side effects from taking part in this study for the group who have already had radiotherapy.

People having radiotherapy for prostate cancer or head and neck cancer will be exposed to slightly more radiation due to the extra images taken during the daily CT scans. This is unlikely to cause you harm, but there is a very small increase in the risk of getting another cancer in the future.