Measuring Oncological Value of Exercise and Statin
MOVES
Syöpäpotilaan Ennusteen Parantaminen Muuttamalla syövän mikroympäristöä ja Metaboliaa Liikunnalla ja lääkkeellisesti - Measuring Oncological Value of Exercise and Statin
1 other identifier
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedStudy Start
First participant enrolled
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 27, 2025
June 1, 2025
4.8 years
February 13, 2023
June 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
From randomization until the date of first documented progression, assessed at twelve week intervals up to 24 months
Mortality
Time to death from the beginning of the first-line medication
From randomization until the date of death, assessed up to 24 months
Secondary Outcomes (10)
Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH)
At baseline and at 3 months
Tolerability of treatment
From date of randomization, assessed at twelve week intervals up to 24 months
Fat/muscle ratio as measured with impedance test
At baseline and at 3 and 6 months
Physical performance with standardized muscle strength tests
At baseline and at 3 and 6 months
Changes in tissue hypoxia
At baseline and at 3 months
- +5 more secondary outcomes
Study Arms (3)
Guided physical exercise arm
EXPERIMENTAL20 patients from each type of cancer (altogether 80) are randomized to a 3 months guided physical exercise arm. At the beginning of the intervention the patients' physical condition and body composition are measured. After that an exercise program begins. All subjects participate in physical exercise program twice a week for three months. At the end of the intervention, the physical condition and body composition are measured again. During the follow-up after the intervention the patients are advised to exercise regularly. Physical condition and body composition are measured again after 6 months. Exercise activity is asked during each follow-up visit. In addition, as a separate group, 20 patients from each type of cancer (altogether 80) who are already using statin medication are randomized to this arm.
Atorvastatin arm
EXPERIMENTAL20 patients from each type of cancer (altogether 80) are randomized to a 3 months guided physical exercise + atorvastatin (40 mg QD) arm. At the beginning of the intervention the patients' physical condition and body composition are measured. After that an exercise program begins. All subjects participate in physical exercise program twice a week for three months. At the end of the intervention, the physical condition and body composition are measured again. During the follow-up after the intervention the patients are advised to exercise regularly. Physical condition and body composition are measured again after 6 months. Exercise activity is asked during each follow-up visit.
Non-guided physical exercise arm
ACTIVE COMPARATOR20 patients from each type of cancer (altogether 80) are randomized to a non-guided physical exercise arm. The patients' physical condition and body composition are measured at baseline. 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. The physical condition and body composition of this group is also measured at three months and six months after baseline to detect changes. After that the patients are given advise to exercise regularly and this is asked during each follow-up visit. In addition, as a separate group, 20 patients from each type of cancer (altogether 80) who are already using statin medication are randomized to this arm.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Tampere Universitycollaborator
- Aalto Universitycollaborator
- University of Helsinkicollaborator
- University of Turkucollaborator
Study Sites (1)
Tampere University Hospital
Tampere, Länsi-Suomi, 33520, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teemu Murtola, MD PhD Prof
Tampere University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology, Chief Physician
Study Record Dates
First Submitted
February 13, 2023
First Posted
April 4, 2023
Study Start
March 31, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share