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Study on the Impact of Exercise and Atorvastatin on Advanced Breast, Ovarian, Prostate, and Kidney Cancer Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of exercise and a medication called atorvastatin on certain types of cancer. The cancers being studied are metastatic breast cancer, ovarian cancer, prostate cancer, and kidney cancer. Metastatic means that the cancer has spread from its original site to other parts of the body. The medication atorvastatin is commonly used to lower cholesterol, but this study is exploring its potential benefits in cancer treatment.

The purpose of the study is to see if supervised group exercise, which includes aerobic and resistance training, can improve the effectiveness of cancer treatment. Additionally, the study will investigate whether combining this exercise with atorvastatin can further enhance the response to cancer therapy. Participants will be divided into groups, with some receiving supervised exercise sessions and others managing their own exercise routines. Some participants will also take atorvastatin, while others may receive a placebo.

The study will take place over a period of time, with participants being monitored for changes in their cancer's progression and overall health. The goal is to determine if these interventions can help slow down the cancer or improve survival rates. This research could provide valuable insights into new ways to support cancer treatment through lifestyle changes and medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have a confirmed diagnosis of metastatic prostate, breast, ovarian, or renal cancer. The patient must be starting their first line of anticancer therapy.
The patient must provide written informed consent to participate in the study.
Step 2
Medication administration
The patient will be administered atorvastatin, which is a medication used to lower cholesterol levels. In this study, it is used to evaluate its effect on cancer treatment.
The medication is provided in the form of film-coated tablets and is taken orally.
Step 3
Exercise regimen
The patient will participate in a supervised group exercise program. This includes both aerobic and resistance training.
The exercise program is designed to be conducted during the anticancer therapy to assess its impact on the treatment's efficacy.
Step 4
Self-administered exercise
In addition to the supervised exercise, the patient will also engage in self-administered exercise routines.
The purpose is to compare the effects of supervised versus self-administered exercise on cancer treatment outcomes.
Step 5
Monitoring and evaluation
Throughout the trial, the patient's cancer progression will be monitored using radiological, biochemical, or clinical evaluations.
The primary endpoint of the study is to assess cancer progression and mortality from the start of the first line of cancer treatment to death.
Step 6
Trial duration
The estimated end date for the trial is December 31, 2026.
The study began recruiting participants on April 1, 2022.

Who can join the trial?

6 criteria

Patients must have **metastatic** cancer, which means the cancer has spread to other parts of the body. This includes breast, ovarian, prostate, or kidney cancer.
The cancer must be confirmed through tests that look at tissue samples (**histologically**) and imaging tests like scans.
Patients should be starting their first line of **anticancer therapy**, which is the initial treatment given for cancer.
Patients must agree to participate in the study and sign a document that explains the study and confirms their consent.
Participants must be adults, meaning they are 18 years old or older.
Women participating in the study must use a reliable method of **contraception** to prevent pregnancy during the trial.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with advanced stages of breast, ovarian, prostate, or kidney cancer cannot participate.
Individuals who are not within the specified age range for the study are excluded. The age range is typically defined by the study organizers.
Participants who cannot engage in supervised group exercise, which includes activities like aerobic (heart-pumping) and resistance (strength-building) training, are not eligible.
Patients who are unable to take atorvastatin, a medication often used to lower cholesterol, in combination with exercise, are excluded.
Individuals who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.

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Pirkanmaan hyvinvointialue
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Tampere, Finland

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Investigated drugs

Atorvastatin
is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can improve the effectiveness of cancer treatment when combined with supervised group exercise. The goal is to determine if atorvastatin can enhance the body's response to anticancer therapy in patients with advanced breast, renal, ovarian, and prostate cancer.
Supervised Group Exercise
involves participating in organized exercise sessions that include both aerobic and resistance training. This therapy is being evaluated to see if it can improve the outcomes of anticancer treatments. The trial aims to compare the effects of supervised group exercise with self-administered exercise to see which approach is more beneficial for patients undergoing cancer therapy.

Atorvastatin

What is already known about the treatment

Atorvastatin – Atorvastatin is administered orally in tablet form. It is currently being studied for its potential benefits in cancer treatment, particularly in combination with exercise, as part of ongoing clinical trials. The main therapeutic indications for atorvastatin include lowering cholesterol and reducing the risk of heart disease, but it is also being explored for its role in enhancing cancer therapy. At the molecular level, atorvastatin works by inhibiting an enzyme involved in cholesterol production, which may also affect cancer cell growth. It is classified as a statin, a type of medication primarily used to manage cholesterol levels.

Investigated diseases

Metastatic Breast Cancer
This type of cancer occurs when breast cancer cells spread to other parts of the body, such as bones, liver, lungs, or brain. It often begins as a localized tumor in the breast and can progress over time to affect distant organs. The disease may cause symptoms like bone pain, difficulty breathing, or neurological issues, depending on where it spreads. The progression can vary greatly among individuals, with some experiencing rapid changes and others having slower disease development.
Metastatic Ovarian Cancer
This cancer starts in the ovaries and spreads to other areas of the body, such as the abdomen, liver, or lungs. Initially, it may present with vague symptoms like bloating or abdominal discomfort. As it progresses, it can lead to more severe symptoms related to the affected organs. The spread of cancer cells can occur through the bloodstream or lymphatic system, leading to widespread involvement.
Metastatic Prostate Cancer
Originating in the prostate gland, this cancer can spread to bones, lymph nodes, or other organs. Early stages might not show significant symptoms, but as it progresses, it can cause bone pain, urinary issues, or fatigue. The disease often spreads through the bloodstream or lymphatic system, affecting various body parts. The rate of progression can differ, with some cases advancing more quickly than others.
Metastatic Kidney Cancer
This cancer begins in the kidneys and can metastasize to lungs, bones, or other organs. Initially, it might be asymptomatic or cause mild symptoms like blood in urine or back pain. As it advances, it can lead to more pronounced symptoms depending on the organs involved. The cancer cells can travel through the bloodstream or lymphatic system, leading to widespread disease.