Does adding progesterone to dexamethasone in patients with brain swelling caused by cancer allow the use of lower doses of dexamethasone in the future?
- Conditions
- Oedema occurring with secondary brain cancersCancer
- Registration Number
- ISRCTN16167828
- Lead Sponsor
- Public Health Scotland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 6
Current participant inclusion criteria as of 27/02/2024:
1. Patients =18 years old
2. Capable of giving informed consent
3. ECOG performance status 0, 1 or 2
4. Diagnosis of cerebral metastases
5. Receiving dexamethasone for control of brain tumour symptoms
6. Ability to swallow oral medication
Previous participant inclusion criteria:
1. Patients =18 years old
2. Capable of giving informed consent
3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
4. Clinical and/or radiological diagnosis of cerebral metastases with peri-tumoural oedema on CT/MRI in the last 14 days
5. Responding symptomatically to dexamethasone for control of brain tumour symptoms at a dose of >8 mg for >48 hours
6. Ability to swallow oral medication
Current participant exclusion criteria as of 27/02/2024:
1. Patients who are unable or unwilling to give informed consent
2. History of unexplained vaginal bleeding
3. Concurrent meningioma
4. On HRT medication
5. History of cholestasis in the last 6 months
6. History of allergy to either progesterone or other ingredients of the trial drug including peanut allergy
7. 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 consent
2. History of unexplained vaginal bleeding
3. Concurrent meningioma
4. On HRT medication
5. History of venous thromboembolic disease, myocardial infarction or stroke in last 12 months
6. History of cholestasis in the last 6 months
7. 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 period
11. Patients participating in Stage 1 will not be eligible for Stage 2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method