About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Guided physical exercise
BehavioralPatients will be participating in guided physical exercise program regularly two times / week at a sports facility and guided by a professional trainer. They will participate in aerobic and resistance exercises during the sessions.
Atorvastatin
DrugPatients will be participating in guided physical exercise program regularly two times / week at a sports facility and guided by a professional trainer. They will participate in aerobic and resistance exercises during the sessions. In addition to the exercise program they will be given atorvastatin 40 mg QD medication.
Independent exercise
Other interventionThe control group is advised of the benefits of physical exercise and they get an exercise program to follow. Participants in the control group exercise on their own.
Treatment groups
Trial outcomes
Primary outcomes
Time to cancer progression
Radiological progression • Radiological progression of the disease according to RECIST criteria (version 1.1.) compared to the situation at the start of cancer treatment in all cancer types. If the cancer treatment includes the use of immune checkpoint inhibitors, the imRECIST criteria are applied to evaluate the response In addition, the disease is considered advanced if both of the criteria below are met: * Biochemical progression: * PSA progression in prostate cancer, (three consecutive PSA increases measured at least one week apart, two \> 50% increases from the lowest PSA level and PSA \> 2 ng/ml) with testosterone at castration level (\< 50 ng/ml or 1.7 nmol/l) * Ca15-3 marker increase in breast cancer (three consecutive marker increases that the clinician considers significant) * In ovarian cancer, ca12-5 marker increase (three consecutive marker increases that the clinician considers significant) * Clinical progression o ECOG 3 or less (long-term)
Mortality
Time to death from the beginning of the first-line medication
Secondary outcomes
Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH)
Hypoxia markers in the serum
Tolerability of treatment
Incidence of grade 3 or worse adverse events during cancer treatment
Fat/muscle ratio as measured with impedance test
Body composition measurement before and after the intervention
Physical performance with standardized muscle strength tests
Muscle strength tested with three standardized tests (squat test, core dynamic strength test, biceps flexion test) before and after the intervention.
Sponsors and contacts
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Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
Aalto University
Collaborator
University of Helsinki
Collaborator
University of Turku
Collaborator