Measuring Oncological Value of Exercise and Statin

NCT ID: NCT05796973

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2027-12-31

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.

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

4) Quality of life, perceived pain, depressive symptoms, nutrition and relationships.

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

Conditions

Prostate Cancer; Breast Cancer; Kidney Cancer; Ovarian Cancer; Metastatic Breast Cancer; Metastatic Kidney Cancer; Metastatic Renal Cell Carcinoma; Metastatic Renal Cancer; Metastatic Prostate Cancer; Metastatic Prostate Adenocarcinoma; Metastatic Ovarian Cancer; Metastatic Ovary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guided physical exercise arm

20 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.

Group Type: EXPERIMENTAL

Guided physical exercise

Intervention Type: 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 arm

20 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.

Group Type: EXPERIMENTAL

Guided physical exercise

Intervention Type: 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

Intervention Type: 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.

Non-guided physical exercise arm

20 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.

Group Type: ACTIVE_COMPARATOR

Independent exercise

Intervention Type: OTHER

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.

Interventions

Guided physical exercise

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.

Intervention Type: BEHAVIORAL

Atorvastatin

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.

Intervention Type: DRUG

Independent exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

Aalto University

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Teemu Murtola

Professor of Urology, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teemu Murtola, MD PhD Prof

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Tampere University Hospital

Tampere, Länsi-Suomi, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Teemu Murtola, MD PhD Prof

Role: CONTACT

teemu.murtola@tuni.fi

03-311611

Jorma Sormunen, MD PhD MBA

Role: CONTACT

jorma.sormunen@fimnet.fi

0505001869

Facility Contacts

Teemu Murtola, MD PhD Prof

Role: primary

teemu.murtola@tuni.fi

Jorma Sormunen, MD PhD MBA

Role: backup

jorma.sormunen@fimnet.fi

Other Identifiers

2019-001982-34

Identifier Type: -

Identifier Source: org_study_id