Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07543432

STATIC - Statin Termination in Cancer

Led by Stiftelsen Stockholms Sjukhem · Updated on 2026-04-21

80

Participants Needed

2

Research Sites

120 weeks

Total Duration

On this page

Sponsors

S

Stiftelsen Stockholms Sjukhem

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

STATIC - Statin Termination in Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • "No" answer to the "surprise question": Would you be surprised if the patient died in the next year?
  • Diagnosed with advanced cancer
  • Receiving ongoing palliative care at the study units
  • For intervention group: Treated with statins for 3 months or more for primary or secondary prevention
  • For control group: Same criteria but no current statin treatment
Not Eligible

You will not qualify if you...

  • Cognitive impairment
  • Does not understand the Swedish language
  • Known homozygous or double heterozygous familial hypercholesterolemia
  • Active cardiovascular disease or high risk requiring ongoing statin medication (assessed by cardiology specialist)
  • Symptoms of myositis
  • Other contraindications to stopping statins

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Stockholms Sjukhem Pallitive Care

Stockholm, Sweden, 11219

Actively Recruiting

2

ASIH Stockholm Södra

Stockholm, Sweden, 12559

Actively Recruiting

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Research Team

L

Linda Björkhem-Bergman, Professor

CONTACT

C

Christel Hedman, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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