Stopping statins in palliative cancer care
STATIC - Statin Termination in Cancer
This pilot will test whether stopping statins is safe and how it affects cholesterol, muscle strength, fatigue, and quality of life in adults with advanced cancer receiving palliative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stiftelsen Stockholms Sjukhem Academic / other |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Trial ID | NCT07543432 on ClinicalTrials.gov |
What this trial studies
This is a prospective pilot study that compares patients with advanced cancer who stop long-term statin treatment to a control group of patients not on statins while receiving palliative care at participating Stockholm centers. The primary outcome is the change in LDL cholesterol (mmol/L) after statin termination, and secondary outcomes include other lipid and steroid markers (cholesterol, HDL, Q10, 25-hydroxyvitamin D, lanosterol), muscle strength, cardiovascular events, fatigue, and quality of life. Eligible intervention participants are adults on statins for at least three months with a limited life expectancy (a “no” answer to the one-year surprise question) and receiving palliative care at the study units; key exclusions include active cardiovascular disease requiring statins, familial homozygous hypercholesterolemia, myositis, cognitive impairment, or inability to understand Swedish. The trial is carried out at Stockholms Sjukhem Palliative Care and ASIH Stockholm Södra with collaboration from Karolinska Institutet.
Who should consider this trial
Good fit: Adults (≥18) with advanced cancer receiving palliative care at the participating Stockholm units, judged unlikely to survive a year by the surprise question, who have been on statins for at least three months and can consent and communicate in Swedish are the ideal candidates.
Not a fit: Patients with active cardiovascular disease or high ongoing cardiovascular risk that requires continued statin therapy, those with familial homozygous/double heterozygous hypercholesterolemia, myositis, or other contraindications to stopping statins are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If stopping statins is safe, patients could avoid unnecessary side effects and pill burden, maintain or improve quality of life, and reduce medication costs and environmental impact.
How similar studies have performed: Deprescribing has been explored in older and palliative populations, but prospective data specifically on stopping statins in palliative cancer patients are sparse, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 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 Exclusion Criteria:h * 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.
Where this trial is running
Stockholm and 1 other locations
- Stockholms Sjukhem Pallitive Care — Stockholm, Sweden (Recruiting)
- ASIH Stockholm Södra — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Linda Björkhem-Bergman — Stiftelsen Stockholms Sjukhem
- Study coordinator: Linda Björkhem-Bergman, Professor
- Email: linda.bjorkhem-bergman@ki.se
- Phone: +46-733-168462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.