A study of progesterone for cancer spread to the brain (PROSSPER)

Cancer type:

Cancer spread to the brain

Secondary cancers

Status:

Open

Phase:

Other

This study is looking at adding progesterone to dexamethasone to reduce swelling in the brain that cancer can cause. It is for people whose cancer has spread to the brain.

This study is taking place in Leeds and Liverpool.

More about this trial

Cancer spread to the brain could cause a build up of fluid around the cancer. This can cause swelling and increasing pressure in your head. This can lead to problems such as headaches and sickness.

The usual treatment for swelling in the brain is the steroid drug dexamethasone. Dexamethasone has side effects including changes in mood, sleep problems and weight gain. These side effects can lower your quality of life Open a glossary item . So doctors are looking for ways to help with this.

We know from early research that progesterone can reduce brain swelling caused by head injuries. Progesterone is a hormone Open a glossary item . Doctors think that adding progesterone to dexamethasone can help people with brain swelling caused by cancer. They hope it will allow them to use lower doses of dexamethasone in the future.

There are 2 parts to this study. Part 1 is looking at the best dose of progesterone to have. Part 2 is testing this dose in more people.

The main aims of the study are to:

find the best dose of progesterone to have with dexamethasone
find out if adding progesterone to dexamethasone improves treatment for brain swelling
see if there are any extra side effects when progesterone is added to dexamethasone
see if taking progesterone allows lower doses of dexamethasone to be used

Please note, you might not get a direct benefit from taking part in the study. The team hope this study might improve treatment for people with swelling in the brain that cancer can cause.

Who can enter

The following bullet points are a summary of 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 join this study if all of the following apply. You:

have cancer that has spread to the brain
are taking a steroid drug called dexamethasone to help with the swelling in the brain
can swallow medication
are up and about more than half the day, you can look after yourself but might not be able to work (performance status 0, 1 or 2)
can give informed consent to take part in the study
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have cancer that started in the brain or spinal cord
have vaginal bleeding and the doctors aren’t sure why
are taking hormone replacement therapy
have a problem with your liver called cholestasis in the last 6 months. Your doctor will know about this.
are allergic to progesterone or anything that it contains
have a peanut allergy
are due to have surgery, chemotherapy or radiotherapy during the study if you join part 2
have any other medical condition that could affect you taking part
are pregnant or breastfeeding

Trial design

This study is taking place in Leeds and Liverpool.

There are 2 parts to the study. The team need about 6 people to join part 1 and 36 people to join part 2.

Part one
Part 1 is open for people to join. It is looking at the best dose of progesterone to have with dexamethasone. You may have already started to take dexamethasone tablets.

In this study you continue taking dexamethasone for 21 days. You also have progesterone tablets on:

day 1 and on
another day between day 5 and day 21

The team will tell you how many tablets to take.

Part 2
Part 2 isn’t open yet. It will open when part 1 finishes.

Part 2 is randomised. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which group you are in.

There are 2 treatment groups. You have 1 of the following:

dexamethasone and progesterone
dexamethasone and a dummy drug (placebo )

PROSSPER trial diagram randomisation

In part 2, you take:

progesterone or the dummy drug tablets every day for 14 days and
take the dexamethasone tablets every day for at least 21 days

The team tell you how many tablets to take.

Your doctor will reduce the dose of dexamethasone over 14 days where possible. They can tell you more about this and the dose to take after 14 days.

Diary and check ups
In part 2, the team ask you to keep a diary. You fill the diary to record when you take the tablets and how many you take. You also speak to a research nurse every day over the phone. This is to check on your symptoms and any possible side effects.

Interview
In part 2 the trial team ask 15 people to take part in an interview. This is to discuss how you felt about the study. The interview takes about 60 minutes. It will be face to face or over the phone. The researcher will ask your permission to tape record and video record the interview. They will treat everything you tell them as confidential Open a glossary item . No one can link the results to you.

You can say no to the interview if you don’t want to take part.

Blood samples for research
For both parts you have some extra blood samples. This is to see what happens to progesterone in the body. Where possible you give the samples at the same time as your routine blood tests.

To have some of the blood tests you might need to stay overnight in the hospital. You don’t have to agree to this if you don’t want to. It won’t affect you taking part in the rest of the study.

Quality of life
The trial team ask you to fill out a questionnaire:

before you start treatment
at set times during treatment
at set times after treatment

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have tests before you can take part. These include:

blood tests
urine tests
a physical examination

Depending on which part you join, you might also need to have a CT scan or an
MRI scan of the brain.

In part 2, you have a check up and neurological examination once a week. This is to check your muscle strength, coordination and memory. You also have a brain scan 2 weeks after you start study treatment.

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 most common side effects of progesterone include: