ISRCTN16167828终止未知
PROgesterone as a Steroid SParing agent against oEdema occurring with secondary bRain cancers (PROSSPER)
Public Health Scotland0 个研究点目标入组 6 人开始时间: 2022年2月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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