A trial looking at treatment to relieve the side effects of radiotherapy to the pelvis (PPALM)

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

Cancer type:

Anal cancer

Bladder cancer

Bowel (colorectal) cancer

Cervical cancer

Ovarian cancer

Prostate cancer

Rectal cancer

Testicular cancer

Transitional cell cancer

Vaginal cancer

Vulval cancer

Womb (uterine or endometrial) cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at the use of a palm oil supplement and a drug called pentoxifylline to relieve bowel symptoms caused by pelvic radiotherapy. It is for people who have had treatment for cancers of the pelvic area, such as bowel cancer, prostate cancer, bladder cancer, womb cancer and ovarian cancer. It is specifically recruiting those people whose symptoms have not responded to the best available standard treatments.

More about this trial

Doctors use radiotherapy to treat a number of different cancers that start in the pelvis area. Unfortunately this treatment can have long term side effects, such as bowel problems. For example, some people may have diarrhoea, leakage of stool, need to rush to the toilet more often than normal or bleeding from the back passage.

These side effects happen if the radiotherapy causes a thickening of the tissue in the treatment area, making it less stretchy. Doctors call this radiation fibrosis. At the moment there is no treatment for radiation fibrosis. But doctors are trying to find ways to relieve the problems caused by this tissue damage.

Laboratory research suggests that a supplement made from palm oil and a drug called pentoxifylline may work well together to reduce this fibrosis and so improve symptoms.

The supplement is made from palm oil and is similar to vitamin E. Pentoxifylline is a drug that has been in use for some years for different medical conditions.

The aims of this trial are to

• Find out if a combination of palm oil supplement and pentoxifylline can reduce the bowel symptoms caused by pelvic radiotherapy
• Learn more about the side effects

Who can enter

You may be able to join this trial if you have had radiotherapy for one of the following

Prostate cancer
Testicular cancer
Bladder cancer
Womb (uterine and endometrial) cancer
Cervical cancer
Vaginal cancer
Vulval cancer
Ovarian cancer
Anal cancer
Cancer of the rectum (you must have had treatment with chemotherapy and radiotherapy and not surgery)

As well as the above, all the following should apply

Your cancer may or may not have spread into lymph nodes nearby, but had not spread to another part of your body
It has been at least 12 months since you finished your radiotherapy, or at least 2 years if you had radiotherapy for a more advanced cancer (the trial team can advise you about this)
There is no sign that your cancer has come back
You have significant side effects following your radiotherapy and these have not been resolved after investigation and treatment by the Royal Marsden bowel specialist team
You are fit and well enough to have the treatment in this trial
You are willing to follow a diet that limits the amount of fat you have each day

You cannot join this trial if any of these apply. You

Have already had treatment with pentoxifylline
Have had a dietary supplement containing more than a daily dose of 30mg of alpha-tocopherol (vitamin E) in the last 3 months
Had your radiotherapy treatment more than 7 years ago
Are pregnant or breast feeding
Are allergic to soya
Are allergic to the drugs used in this trial, or to similar drugs
Have certain heart problems (the trial team can advise you about this)
Have problems with low blood pressure or high blood pressure that cannot be controlled with medication
Have any other medical condition that the trial doctor thinks could affect your taking part
Are taking a non steroidal anti inflammatory drug called ketorolac
Take vitamin K or insulin

Trial design

This is a phase 2 trial, the researchers need 117 people to join. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

People in one group have the palm oil supplement and pentoxifylline. People in the other group have dummy tablets (placebo Open a glossary item ). For every 3 people taking part, 2 people will have the palm oil supplement and pentoxifylline and 1 person will have the dummy tablets.

PPALM trial diagram

You have 2 tablets twice a day and you may have treatment for up to a year.

The trial team will ask you to fill out several questionnaires before you start treatment, every 3 months during treatment and every 6 months for a further year after you finish treatment. The questionnaires will ask

About any symptoms you have had since you finished radiotherapy
How these have affected your life
Whether these side effects have changed since having treatment in this trial

This is called a quality of life study.

Hospital visits

Before you start treatment you will need several visits to hospital to see your specialist doctor. You will have some tests to find out if radiotherapy has caused your symptoms. Your doctor will want to try other things such as medicine or a change in diet to find out if these can help. If you have tried all the available treatments and these do not help, the trial team may ask you to join this trial.

During the trial, you visit the clinic every 3 months for 1 year. When you finish treatment, you go to clinic twice more, after 6 months and then after 1 year.

You are asked to have a blood tests before you start treatment, every 3 months during treatment, then 1 year later. If you don’t want to have these blood tests, you don’t have to. You can still take part in the trial.

The trial team will ask you to fill in a 7 day food diary before you start treatment, then every 6 months for a year. They need to work out the amount of dietary fat you have in your normal diet. This is because dietary fat can affect how well the treatment is absorbed by your body. They may ask you to make some changes to your diet while having the trial treatment.

The researchers will ask for some samples of tissue from your back passage (rectum Open a glossary item ). If you agree, you have a test using a thin tube with a camera attached to look inside the lower part of your bowel. This is called a flexible sigmoidoscopy. During the test, the doctor collects samples of tissue about 2mm in size. They will also take some photos of the inside of your bowel at this time if you agree. You have this before treatment, 1 year after the start of treatment and 1 year after you finish treatment. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

The researchers will look at these samples to see if the appearance of your bowel has changed.

Side effects

People have used this palm oil supplement and have had pentoxifylline for other conditions. But this is the first time people are having these 2 products together to treat radiation fibrosis.

The dose of palm oil supplement used in this trial has no known side effects.

Side effects of pentoxifylline include

Feeling or being sick
Stomach pains
Diarrhoea
Dizziness
Headache
Flushing

Most people who have pentoxifylline do not have side effects.

You must not take high dose vitamin E supplements while having treatment in this trial. This is because having the palm oil supplement and high dose vitamin E together could make you feel very ill.