Measuring Oncological Value of Exercise and Statin

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTampere University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Guided physical exercise

    Behavioral

    Patients 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

    Drug

    Patients 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 intervention

    The 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

240 Participants
are divided into 3 treatment groups
Group A: Guided physical exercise armExperimental treatment 1 intervention
Group B: Atorvastatin armExperimental treatment 2 interventions
Group C: Non-guided physical exercise armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
From randomization until the date of first documented progression, assessed at twelve week intervals up to 24 months
2

Mortality

Time to death from the beginning of the first-line medication

Time frame
From randomization until the date of death, assessed up to 24 months

Secondary outcomes

1

Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH)

Hypoxia markers in the serum

Time frame
At baseline and at 3 months
2

Tolerability of treatment

Incidence of grade 3 or worse adverse events during cancer treatment

Time frame
From date of randomization, assessed at twelve week intervals up to 24 months
3

Fat/muscle ratio as measured with impedance test

Body composition measurement before and after the intervention

Time frame
At baseline and at 3 and 6 months
4

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.

Time frame
At baseline and at 3 and 6 months

Other outcomes

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