STATIC - Statin Termination in Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- LDL levels
研究概览
简要总结
There are many guidelines on when to start drug treatment, but surprisingly few guidelines on how and when to stop drugs. For example, there are currently no clear guidelines on when to stop preventive medications such as statins in patients in palliative cancer care. According to previous studies, these drugs are often deprescribed far too late in the process, often close to death. This can lead to unwanted side effects, such as muscle weakness, increased fatigue, and also contribute to unnecessary drug costs and unnecessary environmental impact.
In the STATIC I study the safety and effects of early deprescribing of statins in palliative cancer care is explored. The primary aim of the STATIC study is to study the change in LDL-levels (mmol/L) after statin termination. The secondary outcomes includes change in levels of other steroids (cholesterol, HDL, Q10, 25-hydroxyvitamin D, lanosterol), change in muscle strength, cardiovascular events, fatigue and quality of life after statin deprescribing. STATIC I is a pilot study to optimize the design for the randomized study STATIC II.
The study aim at including 40 patients with advanced cancer within specialized palliative care with an expected survival time >1 month to <1 year (surprise question 1 year). At start of the study statins are deprescribed and the patients are followed for 12 weeks. Data collection is performed at baseline, 2, 4, 8 and 12 weeks. A control group (n=40) comprising patients with advanced cancer and no ongoing statin treatment, are included from the same specialized palliative care units. The control group is followed for 12 weeks regarding muscle strength and symptom burden.
The current studies can provide important and valuable knowledge on the safety and effects of early describing.
详细描述
STATIC - statin termination in cancer
Purpose and Aims To reduce overtreatment of statins in palliative cancer care. To this end, a prospective pilot study in patients with advanced cancer to evaluate effects and safety of deprescribing statins is performed.
Hypotheses
Statin treatment might do more harm than good in patients with advanced cancer with a limited life expectancy (less than 1 year) and should be discontinued earlier in the disease trajectory than is standard practice today.
Background Palliative Care and deprescribing Palliative medicine aims at providing relief from symptoms in incurable diseases and at maintaining functions and a high quality of life (QoL), i.e. "to live every day until you die". In medical treatment in palliative care, side effects should be minimized and should not outweigh possible beneficial effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intervention arm:
- •≥ 18 years,
- •"No"-answer to the "surprise question" 1 year: Would you be surprised if this patient died in the next year? (this is a common and validated prognostic tool in palliative care)
- •advanced cancer
- •ongoing palliative care at the the unit study units
- •treatment with statins ≥ 3 months for primary or secondary prevention before study inclusion
- •Inclusion Criteria control-group:
- •Same as above but no statin treamnet
排除标准
- •Cognitive impairment
- •Does not understand the Swedish language
- •Known homozygous or double heterozygous familial hypercholesterolemia
- •Active cardiovascular disease or sufficient risk of active cardiovascular disease that requires ongoing medication with statins (assessed by a specialist in cardiology)
- •myositis symptoms
- •Other contraindications to deprescribe statins.
研究组 & 干预措施
Intervention arm, deprescribing statins
In patients with advanced cancer, statins are deprescribed at inclusion addmitted to palliative care. Patients are follwed at inclusion and at 2, 4, 8 and 12 weeks with laboratory tests (cholesterol, routine laboratory tests) and questionnaires (ESAS, EORTC QLQ-C15 PAL, EQ-5D and TSQM-9) and muscle strength. Side-effect, especially cardiac events, are monitored.
干预措施: Deprescribing statins (Drug)
结局指标
主要结局
LDL levels
时间窗: 12 weeks
Changes in LDL levels (mmol/L) after statin termination.
次要结局
- Steroid levels(12 weeks)
- Change in quality of life(12 weeks)
- Fatigue(12 weeks)
- Muscle-strength(12 weeks)
研究者
Linda Björkhem Bergman
MD PhD
Stiftelsen Stockholms Sjukhem