Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Chris Twelves
+44 (0)113 206 8186
C.J.Twelves@leeds.ac.uk


Dr Prossper Study Team
+44 (0)131 275 7058
phs.prossper@phs.scot


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Does adding progesterone to dexamethasone in patients with brain swelling caused by cancer allow the use of lower doses of dexamethasone in the future?
Back

Does adding progesterone to dexamethasone in patients with brain swelling caused by cancer allow the use of lower doses of dexamethasone in the future?

Stopped

Open to: All Genders

Age: Adult

Leeds Liverpool

Medical Conditions

Oedema occurring with secondary brain cancers

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
Corticosteroids, and in particular dexamethasone, remain central to the management of patients with brain tumours, despite their frequent and often serious side effects. Furthermore, there is increasing evidence that patients who remain on corticosteroids fare worse than those in whom steroids can be withdrawn and not simply because they have worse disease; possible explanations include a radio-protective effect and impaired immune response. The need for an alternative to corticosteroids has become increasingly recognised, but to date no such alternative has been identified. Progesterone is also a steroid, with neuroprotective and anti-inflammatory properties in pre-clinical models, but fewer side effects in patients. Progesterone warrants investigation as an alternative to corticosteroids for patients with brain tumour induced oedema. Unfortunately, pre-clinical models of brain tumours do not replicate the oedema (build-up of fluid) seen in patients, so laboratory studies are of limited value. In addition, the dose of progesterone to achieve optimal drug exposure is unclear. This trial in patients with brain tumours and oedema will investigate the pharmacokinetics (what the body does to the drug) of differing doses of oral progesterone. The researchers also hope to obtain preliminary evidence as to whether the addition of progesterone allows a greater reduction in the dose of dexamethasone for these patients. If successful, this trial will underpin a definitive trial studying the effectiveness of progesterone in patients with primary and metastatic brain tumours with oedema.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Oct 2022 01 Jul 2025

Stage 1: Participants will receive a single oral dose of 200 mg micronised progesterone on Day 1 and a second single 600 mg dose 5 -21 days later. Blood samples will be collected to measure drug levels after each dose of progesterone. Participants will also receive dexamethasone dose on Day 1 but this will be reduced as clinically indicated on other days.
Stage 2: Participants will receive oral micronised progesterone or placebo three times a day and a dose of dexamethasone. The progesterone or placebo will only be taken daily for 14 days. The daily dexamethasone dose will be the same on both sampling days, but can be adjusted as clinically indicated between the sampling days. The treating clinician will advise the dose to take each day. Blood samples will be collected to measure drug and hormone levels; participants will also be asked to complete questionnaires and an interview.


Patients aged 18 years and over with secondary brain cancers with oedema

You can take part if:



You may not be able to take part if:


Current participant exclusion criteria as of 27/02/2024:1. Patients who are unable or unwilling to give informed consent2. History of unexplained vaginal bleeding3. Concurrent meningioma4. On HRT medication5. History of cholestasis in the last 6 months6. History of allergy to either progesterone or other ingredients of the trial drug including peanut allergy7. Pregnant or lactating (all female patients of childbearing age will undergo pregnancy testing enrolment (Stage 1)/ randomisation (Stage 2)8. Clinically significant co-morbidities that in the opinion of the investigator would preclude study participation 9. * Planned surgery, chemotherapy, or radiotherapy within the study treatment period*Stage 2 only. In Stage 1 there is no tumour assessment so the second micronized progesterone dose (with dexamethasone and pharmacokinetic sampling) can be after any local treatment provided the interval between trial dosing days is no more than 21 days

10. Patients participating in Stage 1 will not be eligible for Stage 2





Previous participant exclusion criteria:1. Patients who are unable or unwilling to give informed consent2. History of unexplained vaginal bleeding3. Concurrent meningioma4. On HRT medication5. History of venous thromboembolic disease, myocardial infarction or stroke in last 12 months6. History of cholestasis in the last 6 months7. History of allergy to either progesterone or other ingredients of the trial drug including peanut allergy.8. Pregnant or lactating (all female patients of childbearing age will undergo pregnancy testing prior to randomisation)9. Clinically significant co-morbidities that in the opinion of the investigator would preclude study participation 10. Planned surgery, chemotherapy or radiotherapy within the 14-day study treatment period11. Patients participating in Stage 1 will not be eligible for Stage 2


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • Clatterbridge Cancer Centre
    65 Pembroke PLACE
    Liverpool
    L7 8YA

Benefits: Hopefully this study drug will help reduce the swelling in the brain caused by the brain tumour and will have few, or minor, side effects. It is also hoped that this may be a better treatment than the current medication that is routinely given to patients. It is hoped that this research will teach us more about this type of cancer and how it can be treated. This may enable us to improve the standard of treatment to help other patients with cancer in the future.
Risks:
Stage 1: Participants may be required to attend the clinic more often than people who are not in the study. This is because the research staff may want to see them more often to check on progress.
On two occasions participants will be asked to provide blood samples and given the option of staying overnight at the hospital for these blood samples to be collected. The researchers would expect most patients to be vaccinated against COVID-19 and all precautions will be in keeping with guidance at the time for hospital attendances.
Stage 2: Participants may be required to attend the clinic more often than people who are not in the study. This is because the research staff may want to see them more often to check on progress.
On up to four occasions participants will be asked to provide blood samples and given the option of staying overnight at the hospital for these blood samples to be collected. The researchers would expect most patients to be vaccinated against COVID-19 and all precautions will be in keeping with guidance at the time for hospital attendances. Before they start the trial, and on day 14, participants will have either a CT or an MRI scan of the brain. If participants have CT scans, this uses ionising radiation (x-rays). Ionising radiation may cause cancer many years or decades after the exposure but the chance of this happening is extremely small. If participants have the MRI scan, this can be noisy and claustrophobic. The MRI scan may require the injection of a contrast agent into a vein to allow the cancer to be better seen. This may cause side effects in a small minority of participants.

Dr Prossper Study Team
+44 (0)131 275 7058
phs.prossper@phs.scot


Prof Chris Twelves
+44 (0)113 206 8186
C.J.Twelves@leeds.ac.uk



The study is sponsored by Public Health Scotland and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR130966.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN16167828

Or CPMS 51758

Last updated 20 August 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top