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STATIC - Statin Termination in Cancer

NCT07543432 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-21

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Linda Björkhem-Bergman · Stiftelsen Stockholms Sjukhem

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543432 on ClinicalTrials.gov