STATIC - Statin Termination in Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• LDL levels — 12 weeks
  Changes in LDL levels (mmol/L) after statin termination.

Trial sites (2)

Other trials for the same condition