Evaluation of Atorvastatin and Supervised Exercise on Anticancer Therapy Efficacy in Metastatic Breast, Ovarian, Prostate, and Kidney Cancer

The primary objective of the study is to evaluate whether **supervised group exercise** incorporating aerobic and resistance training during anticancer therapy enhances the efficacy of treatment in patients with advanced **breast**, **renal**, **ovarian**, and **prostate cancer** compared to self-administered exercise. Additionally, the study aims to determine if the combination of atorvastatin with supervised group exercise further improves the response to cancer treatment. This is clinically relevant as it explores potential non-pharmacological and pharmacological interventions that could optimize cancer therapy outcomes.

Secondary objectives include assessing whether exercise alone can sufficiently reduce hypoxia to improve chemotherapy efficacy and if the inhibition of lipid synthesis with statins enhances this effect. The study also aims to explore patients' experiences regarding the impact of cancer treatment, its side effects, and increased physical activity on their quality of life, depressive symptoms, pain, diet, and relationships. These objectives are significant as they address the holistic impact of cancer treatment and lifestyle modifications on patient well-being and treatment efficacy.

The clinical trial involves participants diagnosed with **metastatic breast, ovarian, prostate, and kidney cancer**. The study population includes both male and female adults, aged 18 years and older, who are initiating first-line anticancer therapy. Participants are required to have histologically and imaging-confirmed metastatic cancer. The trial does not include vulnerable populations. The selection process involves obtaining informed consent from patients who meet the inclusion criteria, which also stipulates that women must use a reliable method of contraception during the trial. The sponsor has not provided information regarding the total number of participants. The trial examines the impact of supervised group exercise, incorporating aerobic and resistance training, on the efficacy of anticancer therapy, with additional consideration of atorvastatin use. Participants' lifestyle factors, such as diet and physical activity, are relevant to the study's objectives, although specific lifestyle criteria are not detailed in the available data.

The clinical trial is designed to evaluate the efficacy of **atorvastatin** combined with supervised group exercise in improving the response to anticancer therapy in patients with metastatic breast, ovarian, prostate, and kidney cancer. This is a Phase II, randomized, double-blind, controlled trial. The trial is expected to run from April 2022 to December 2026, with participant involvement lasting up to 90 days. The study will include an initial screening visit to confirm eligibility, followed by regular follow-up visits to monitor the participants' health and response to treatment. The end-of-study visit will assess the primary endpoint, which is cancer progression and mortality, evaluated from the start of the first-line cancer treatment to death.

Participants will be randomly assigned to either a supervised group exercise program with aerobic and resistance training or a self-administered exercise regimen. The trial will also assess whether the addition of **atorvastatin** enhances the efficacy of the anticancer therapy. The inclusion criteria require participants to have histologically and imaging-confirmed metastatic cancer and to be initiating first-line anticancer therapy. Participants must provide informed consent and, if applicable, use reliable contraception during the trial. The trial will exclude individuals who do not meet these criteria. Early termination from the study may occur if participants experience significant adverse effects or if they withdraw consent. The trial aims to provide valuable insights into the potential benefits of combining exercise and **atorvastatin** in cancer treatment.

The clinical trial involves the administration of **Lipistad 40 mg film-coated tablets**, which contain the active substance **atorvastatin**. Atorvastatin is a chemical compound classified under the ATC code C10AA05, commonly used as a cholesterol-lowering drug. The pharmaceutical form of the medication is a film-coated tablet, designed for oral administration. Participants in the trial will receive a maximum daily dose of 40 mg, with the total dose not exceeding 3600 mg over the course of the study. The maximum treatment period is set at 90 days. The medication is manufactured by STADA Arzneimittel AG and is not a pediatric formulation.

In addition to the experimental treatment with atorvastatin, the study also incorporates a supervised group exercise regimen, which includes aerobic and resistance training. This exercise component is designed to evaluate its impact on the efficacy of anticancer therapy in patients with advanced breast, renal, ovarian, and prostate cancer. The trial aims to determine whether the combination of atorvastatin and supervised exercise further enhances the response to cancer treatment compared to self-administered exercise alone. Compliance with the dosing schedule and exercise regimen will be monitored throughout the study to ensure adherence to the protocol.

Efficacy in the clinical trial titled "Measuring Oncological Value of Exercise and Statin (MOVES)" will be assessed using primary endpoints that include **cancer progression** and mortality. Cancer progression will be evaluated through radiological, biochemical, or clinical assessments, while mortality will be measured by the time from the initiation of first-line cancer treatment to death. These endpoints are designed to determine whether supervised group exercise with aerobic and resistance training during anticancer therapy enhances the efficacy of anticancer treatment in patients with advanced breast, renal, ovarian, and prostate cancer, compared to self-administered exercise. Additionally, the trial will assess if the use of **atorvastatin** in combination with supervised group exercise further improves the response to cancer treatment.