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Prostate CancerPhase 3MOVESNCT05796973

Measuring Oncological Value of Exercise and Statin

A Phase 3 study testing Guided physical exercise, Atorvastatin and Independent exercise in people with Prostate Cancer and Breast Cancer, run by Tampere University Hospital at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Prostate Cancer, Breast Cancer, Kidney Cancer
What is being tested?
Guided physical exercise, Atorvastatin and Independent exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteFinland
Study dates
31 Mar 2023to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Teemu Murtola, MD PhD Prof contact

03-311611

teemu.murtola@tuni.fi

Jorma Sormunen, MD PhD MBA contact

0505001869

jorma.sormunen@fimnet.fi

Finland1 site, 1 recruiting
  • Tampere University Hospital

    Tampere, Länsi-Suomi, 33520

    Teemu Murtola, MD PhD Prof, teemu.murtola@tuni.fi

    Jorma Sormunen, MD PhD MBA, jorma.sormunen@fimnet.fi

    Recruiting

Other trials in Finland

About this study

Official title: Syöpäpotilaan Ennusteen Parantaminen Muuttamalla syövän mikroympäristöä ja Metaboliaa Liikunnalla ja lääkkeellisesti - Measuring Oncological Value of Exercise and Statin

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.

Read the detailed description

Despite the marked differences between different malignancies' genetic, metabolic, and prognostic factors, hypoxia and adaptation of metabolic changes favoring hypoxic microenvironment are common factors in most solid tumors. Hypoxic microenvironment provides cancer cells multiple advantages: protection from immune system, somatic mutations leading to more aggressive form of cancer, and cancer cells that are adjusted to hypoxic conditions are more prone to form metastases. One possible mechanism for cancer cell to adjust to hypoxic microenvironment is related to lipid metabolism; lipids are known to accumulate into cancer cells in many cancer types. One of the most promising ways to reduce hypoxia in solid tumors is to increase physical exercise. Furthermore, tumors' lipid metabolism can be affected by treatment with cholesterol-lowering statins, which decreases serum cholesterol levels and inhibits cancer cells' own lipid synthesis.

The aim of this randomized clinical trial is to investigate if supervised group exercise will improve response to cancer drug treatment in metastasized breast, kidney, prostate, and ovarian cancer compared to unsupervised exercise. The investigators will also evaluate if atorvastatin treatment in combination with guided group exercise can promote even better treatment responses than exercise alone. Exercise program includes aerobic and resistance training.

This study is a randomized phase III study testing the research hypothesis for the first time in humans. A total of 240 cancer patients (n=60/cancer type) will be recruited into the study and randomized 1:1:1 into three different groups, i.e. 20 people in each group from each cancer type:

  1. 3 months of supervised group exercise
  2. 3 months of supervised group exercise and at the same time atorvastatin 40 mg/day
  3. to a control group that exercises voluntarily without guidance.

In addition, as a separate group, a total of 160 cancer patients (40/cancer type) who are already using statin medication will be recruited for the study and randomized 1:1 into two groups: 1) 3 months of supervised group exercise and 2) independent exercise (a control group that exercises voluntarily without guidance).

Before the study begins, the patients are informed orally and in writing about the study. The patients who agree to participate in the study sign an informed consent.

The patient follow-up time in each group is two years in 3 months intervals (first visit and 8 follow-up visits) in conjunction with standard cancer treatment follow-up visits. Blood and urine samples and questionnaire data are collected at baseline and at each follow-up visit. Body composition and physical performance are measured at baseline and twice after the intervention. Patients QoL and experiences of exercise are measured in qualitative interviews (in the group participating the qualitative sub-study).

The main response variables are

  1. cancer progression during cancer treatment based on imaging, symptoms or laboratory findings and
  2. mortality of the patients. The other variables of interest in this study are:
  3. Hypoxia markers
  4. Tolerability of treatment
  5. Body composition
  6. Physical performance
  7. The extent of hypoxia, as measured by PET scans, in participants of the sub-study
  8. Quality of life, perceived pain, depressive symptoms, nutrition and relationships.

Adverse events from cancer treatment and treatment interruptions are also monitored.

Being tested
Guided physical exercise, Atorvastatin, Independent exercise
Medical subject headings
Prostatic Neoplasms, Breast Neoplasms, Kidney Neoplasms, Ovarian Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided physical exerciseBehavioural

    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.

  • AtorvastatinDrug

    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 exerciseOther

    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.

Study groups in NCT05796973
Study groupRoleWhat they receive
Guided physical exercise armExperimental20 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.
Receives: Behavioral: Guided physical exercise
Atorvastatin armExperimental20 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.
Receives: Behavioral: Guided physical exercise; Drug: Atorvastatin
Non-guided physical exercise armActive 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.
Receives: Other: Independent exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: From randomization until the date of death, assessed up to 24 months

Secondary outcomes (10)
  1. Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH)

    Hypoxia markers in the serum

    Measured: At baseline and at 3 months

  2. Tolerability of treatment

    Incidence of grade 3 or worse adverse events during cancer treatment

    Measured: 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

    Measured: 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.

    Measured: At baseline and at 3 and 6 months

  5. Changes in tissue hypoxia

    The amount of hypoxia in cancer foci determined by PET-CT scan using specific hypoxia-sensitive tracers in a sub-study

    Measured: At baseline and at 3 months

  6. Changes in quality of life

    EORTC-QLQ-C30 questionnaire to measure quality of life, score from 0 to 100. A high scale score for a functional scale represents a higher level of functioning, a high score for a symptom scale represents higher level of symptoms.

    Measured: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months

  7. Depressive symptoms

    Patient Health Questionnaire (PHQ-9), score from 0 (no depression) to 27 (severe depression).

    Measured: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months

  8. Severity of pain

    The severity of pain and its impact on functioning. Brief Pain Inventory questionnaire including 9 items. Pain severity scale from 0 (no pain) to 10 (worst pain), pain interference from 0 (does not interfere) to 10 (completely interferes).

    Measured: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months

  9. Nutritional status

    Mini Nutritional Assessment (MNA) questionnaire. A score of 7 or less (malnutrition) to 24-30 (normal nutrition).

    Measured: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months

  10. Relationship satisfaction

    The relationship questionnaire consists of two previously used, validated measures: Dyadic Adjustment Scale (DAS) and Marital Communication Inventory.

    Measured: At baseline and at three months, twelve months and 24 moths.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start31 Mar 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients are randomized equally into three groups: 1/3 into guided exercise group, 1/3 into guided exercise and statin-treatment group and 1/3 into non-guided exercise group
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796973
Sponsor's protocol ID
2019-001982-34
Other IDs
2019
Acronym
MOVES
Status last verified
Jun 2025
First submitted
13 Feb 2023
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guided physical exercise, Atorvastatin and Independent exercise in people with Prostate Cancer and Breast Cancer, run by Tampere University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Teemu Murtola, MD PhD Prof (03-311611, teemu.murtola@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cancer progression (time frame: From randomization until the date of first documented progression, assessed at twelve week intervals up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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Measuring Oncological Value of Exercise and Statin | AzTrials