STATIC - Statin Termination in Cancer

NCT07543432 | Recruiting DMC

• 1 other identifier: 2025-07285-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Cancer

Keywords

palliative care; statins; cancer; deprescribing

Outcome Measures

Primary Outcomes (1)

• LDL levels

  Changes in LDL levels (mmol/L) after statin termination.

  12 weeks

Secondary Outcomes (9)

• Steroid levels

  12 weeks

• Change in quality of life

  12 weeks

• Fatigue

  12 weeks

• Muscle-strength

  12 weeks

• Steroid levels

  12 weeks

Study Arms (1)

Intervention arm, deprescribing statins

EXPERIMENTAL

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.

Drug: Deprescribing statins

Interventions

Deprescribing statins DRUG

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.

Also known as: Laboratory tests

Intervention arm, deprescribing statins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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
• Same as above but no statin treamnet

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiftelsen Stockholms Sjukhem: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Stockholms Sjukhem Pallitive Care

Stockholm, 11219, Sweden

RECRUITING

ASIH Stockholm Södra

Stockholm, 12559, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Clinical Laboratory Techniques

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Linda Björkhem-Bergman

  Stiftelsen Stockholms Sjukhem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Björkhem-Bergman, Professor

CONTACT

+46-733-168462; linda.bjorkhem-bergman@ki.se

Christel Hedman, PhD

CONTACT

+46-72-5824409; christel.hedman@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: Single arm study where every patient is its own control. Since all patients in the intervention group are severy ill and the natual course of the disease includes having less muscle strength and more symptoms a control group with similar patients form palliative care is added with and followed for the same 12 weeks with muscle strength, symptom burden and cardiovascular events.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 21, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)