Measuring Oncological Value of Exercise and Statin
Recruiting · NCT05796973 · Interventional (participants receive a specific treatment) · Lead sponsor: Tampere University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The aim of the study is to find out whether supervised physical exercise during cancer drug treatment improves the effectiveness of the treatment in metastasized breast, kidney, ovarian and prostate cancer compared to unsupervised exercise. In addition, the investigators are investigating whether the use of atorvastatin combined with guided group exercise training would further improve the response to cancer treatment.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The patient has metastatic prostate cancer, breast cancer, ovarian cancer or kidney cancer confirmed histologically and by imaging, for which 1st-line cancer drug treatment is started
- Prostate cancer: First course of docetaxel treatment or second-generation antiandrogen treatment for metastatic prostate cancer.
- Breast cancer: First-line medical treatment of metastatic breast cancer regardless of hormone receptor status.
- Kidney cancer: Kidney cancer, for which 1st-line cancer drug treatment is started as tki monotherapy and/or IO monotherapy or as a combination therapy.
- Ovarian cancer: stage III or IV cancer for which chemotherapy treatment is started.
- The patient agrees to the study and signs a written informed consent.
- Adult (18 years=\>) women (breast, ovarian and kidney cancer) and men (prostate and kidney cancer) are recruited for the study.
- In women, the use of a reliable contraceptive during the intervention
Exclusion criteria
- High risk of bone fractures
- Inability to physical exertion and/or unsuitability for cancer drug treatment
- Poor co-operation ability for psychological reasons
- Active use of cholesterol-lowering drugs
- Severe liver or kidney failure
- Troublesome side effects that occurred in the past during cholesterol medication
- Continuous use of medicinal substances that interact with atorvastatin during the study period
- A special group of subjects according to the EU Clinical Trials Regulation 536/2014 (e.g. pregnant or lactating women)
- Exclusion criteria in patients who are already using statin medication before the study:
- High risk of bone fractures
- Inability to physical exertion and/or unsuitability for cancer drug treatment
- Poor co-operation ability for psychological reasons
- Severe liver or kidney failure
- A special group of subjects according to the EU Clinical Trials Regulation 536/2014 (e.g. pregnant or lactating women)
Where it is running
1 location listed.
- Tampere University Hospital - Tampere, Länsi-Suomi, Finland