PROSSPER

• Research type

  Research Study

• Full title

  PROgesterone as a Steroid SParing agent against oEdema occurring with secondary bRain cancers

• IRAS ID

  1004104

• Contact name

  Chris Twelves

• Contact email

  C.J.Twelves@leeds.ac.uk

• Sponsor organisation

  Public Health Scotland

• Eudract number

  2021-003171-34

• ISRCTN Number

  ISRCTN16167828

• Research summary

  Patients that have brain tumours often have swelling in their brain caused by the tumour. This swelling can cause headaches, sickness and sometimes seizures (epileptic fits). The normal way to treat this swelling is to use a medicine called dexamethasone. Unfortunately, dexamethasone has side effects including change in mood, sleep problems & weight gain. Patients with brain tumours can take dexamethasone for long periods & these side effects can lower their quality of life.
  Progesterone is a naturally occurring chemical in the body and has been used in contraceptive (pregnancy prevention) tablets for several decades and has few side effects.
  Progesterone has been used in animal models to look at head injury and has been shown to reduce swelling. In animal models, brain tumours do not cause as much swelling as in humans. The first thing we need to find out if the dose (amount) of progesterone that will provide the most effective level in the patient’s blood. This will be Stage 1.
  Once confirmed, we then need to make sure that patients with brain tumours do not have any unexpected side effects. This part of the study will involve finding out about patients’ quality of life. This will be Stage 2.
  If the Prossper study is successful, then a larger trial will be needed to compare two groups of patients – those taking dexamethasone and those taking a lower dose of dexamethasone plus progesterone.

  The two stages are:
  Stage 1: 6-12 patients will be enrolled at Leeds Hospital. These patients will take the current treatment, dexamethasone, and at two timepoints, patients will be given the study drug - progesterone. This stage is 10 days.

  Stage 2: 36 patients will be recruited to take part at either Leeds or Liverpool Hospital. These patients will all be prescribed the current treatment, dexamethasone. In addition, 18 of these patients will be randomly selected to receive progesterone. The other 18 will receive a dummy tablet - placebo. This stage is 22 days.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  21/EE/0262

• Date of REC Opinion

  23 Dec 2021

• REC opinion

  Further Information Favourable Opinion