Impact of Exercise and Statins on Cancer Treatment
Syöpäpotilaan Ennusteen Parantaminen Muuttamalla syövän mikroympäristöä ja Metaboliaa Liikunnalla ja lääkkeellisesti - Measuring Oncological Value of Exercise and Statin
This study is testing if doing supervised exercise while taking cancer drugs helps people with metastatic breast, kidney, ovarian, and prostate cancer feel better and respond better to their treatment compared to exercising on their own, and if adding a cholesterol-lowering medication can make it even more effective.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tampere, Länsi-Suomi) |
| Trial ID | NCT05796973 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if supervised physical exercise during cancer drug treatment enhances the effectiveness of the treatment for patients with metastatic breast, kidney, ovarian, and prostate cancer compared to unsupervised exercise. Additionally, the study investigates whether atorvastatin, a cholesterol-lowering medication, combined with guided group exercise can further improve treatment responses. The exercise program includes both aerobic and resistance training, and the trial is randomized to ensure robust results. The study focuses on the relationship between exercise, statin use, and cancer treatment efficacy in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed metastatic prostate, breast, kidney, or ovarian cancer who are starting their first-line cancer drug treatment.
Not a fit: Patients with early-stage cancer or those not starting first-line treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with metastatic cancers through enhanced exercise and statin use.
How similar studies have performed: Other studies have shown promising results with exercise interventions in cancer treatment, but the combination with atorvastatin is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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) 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)
Where this trial is running
Tampere, Länsi-Suomi
- Tampere University Hospital — Tampere, Länsi-Suomi, Finland (Recruiting)
Study contacts
- Principal investigator: Teemu Murtola, MD PhD Prof — Tampere University Hospital
- Study coordinator: Teemu Murtola, MD PhD Prof
- Email: teemu.murtola@tuni.fi
- Phone: 03-311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.