A study of treatment to prevent radiation fibrosis that radiotherapy to the head and neck cancer can cause (PenVe)

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

Cancer type:

Head and neck cancers

Mouth and oropharyngeal cancer

Nasopharyngeal cancer

Salivary gland cancer

Status:

Closed

Phase:

Pilot

This study is looking at whether vitamin E and pentoxifylline can prevent tissue damage and a jaw problem called osteoradionecrosis.

It is for people having radiotherapy for cancer of the head and neck. The study is taking place at Guy’s and St Thomas’ Hospital in London.

More about this trial

Radiotherapy to the head and neck can cause a dry mouth, jaw stiffness and swallowing problems. Radiation harms the healthy gums that cover your jaw bone and the bone can become exposed. This is called ‘osteoradionecrosis’ or ORN. It is a difficult condition to treat.

Radiotherapy can make tissue less stretchy. This is called radiation fibrosis. Over time the fibrosis gets worse. It can cause worsening jaw stiffness and swallowing difficulties. This increases the risk of developing ORN.

Researchers are looking for ways to avoid, delay or stop radiation fibrosis developing. They hope that preventing it might help stop ORN.

In this study they are looking at 2 drugs called pentoxifylline and vitamin E. These are already a treatment for ORN once it has started.

In the study some people have pentoxifylline and vitamin E. And some have standard care. This includes regular check ups with a dentist.

The main aims of the study are to find out:

how many people agree to take part
if having these 2 drugs prevents radiation fibrosis and ORN
more about the side effects of pentoxifylline and vitamin E

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to take part if you are having radiotherapy for head and neck cancer and have a high risk of developing:

problems opening your mouth
problems swallowing
osteoradionecrosis (ORN)

The study includes the following types of head and neck cancers:

cancer at the base of the tongue, tonsil cancer or mouth cancer. This is called mouth and oropharyngeal cancer.
cancer that starts in a part of the throat called the nasopharynx (nasopharyngeal cancer)
cancer that starts behind your cheeks (maxillary sinus)
salivary gland cancer
cancer in the neck but doctors don’t know where it started. This is called unknown primary of the neck.
cancer in a part of the throat called the hypopharynx

Diagram 2

As well as the above the following must also apply. You are:

having treatment with the aim to cure your cancer
at least 18 years old

Who can’t take part

You cannot join this study if any of these apply.

Cancer related
You can’t take part if you:

have cancer that has spread elsewhere in the body
have had cancer of the head and neck in the past
are having treatment to help with symptoms caused by cancer (palliative care)
have a high risk of the cancer coming back after treatment
are taking part in another clinical trial that is testing drugs

Medical conditions

You can’t take part if:

you have had a stroke or a serious bleed in your eye
you have certain heart problems such as a heart attack
your liver or kidneys don’t work properly
you have had treatment that causes a condition called osteonecrosis of the jaw such as bisphosphonates or denosumab
you have any other medical condition that the study team think would affect you taking part

Other
You can’t take part if you:

are allergic or sensitive to pentoxifylline and vitamin E or anything they contain
are taking a medication called theophylline or hormone replacement therapy (HRT)
are pregnant or breastfeeding

Trial design

The study is taking place at Guy’s and St Thomas’ Hospital in London.

Before running a large study, the researchers first need to find out if it is possible to do it. So, they are running this feasibility study. The researchers hope to find 68 people to take part.

It is a randomised study. There are 2 groups. Neither you nor your doctor can decide which group you are in.

For every 3 people having pentoxifylline and vitamin E, 1 person will have standard care. You have 1 of the following:

pentoxifylline and vitamin E
standard care (the control group )

Diagram 1

Pentoxifylline and vitamin E group
In this group you start treatment 3 months after you finish radiotherapy. The study team tell you when to start treatment.

You have pentoxifylline as a liquid or a tablet. You take it twice a day, every day.

You have vitamin E as a liquid or a tablet. You take it once a day every day.

You have treatment for 6 months.

The study team contact you by phone to see how you are feeling and if you are having any side effects. They call you:

every day for the first 2 weeks of having treatment and then
every 3 weeks until the end of the study

Standard of care group
In this group you have the best standard of care. This includes:

a check up with a dentist before radiotherapy (you might need to have some teeth removed before you have radiotherapy)
the dentist providing you with instructions to keep your mouth clean (oral hygiene)
keeping up with your oral hygiene during radiotherapy
having regular 6 monthly check ups with a dentist

Both groups
You see the study team for a check up:

before you start radiotherapy
after you have finished radiotherapy and then
at 3 months (only for the medication group to collect their tablets)
at 6 months
at 9 months

The team carry out a mouth exam and see if you have any problems opening and closing your mouth. You also have a blood test.

Focus groups
The researchers may also ask you to meet with the trial doctor and others who took part in the study. This is to find out what you thought about it.

The team ask your permission for any discussions to be audio-recorded.

The focus groups take place at Guy’s Hospital in London. The team let you know more about them and when they are happening.

You don’t have to agree to take part in the focus groups if you don’t want to. You can still take part in the main part of the study.

Quality of life
The study team ask you to fill out 2 questionnaires before you join the study and at set times during and after the study. One questionnaire asks about side effects and how you’ve been feling. This is called a quality of life study. The other asks about any swallowing problems you may have.

Diary
You have a diary to write down when you took pentoxifylline and vitamin E. You also write down any side effects you have and any questions you might have.

Hospital visits

You have 4 to 5 hospital visits if you join the study. Most of these take place when you have routine check ups at the hospital.

Side effects

The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

The side effects of pentoxifylline and vitamin E are mild. The common side effects include: