RecruitingPhase 3NCT05796973

Measuring Oncological Value of Exercise and Statin

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


Sponsor

Tampere University Hospital

Enrollment

240 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria8

  • 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 Criteria13

  • 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)

Interventions

BEHAVIORALGuided 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.

DRUGAtorvastatin

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.

OTHERIndependent 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.


Locations(1)

Tampere University Hospital

Tampere, Länsi-Suomi, Finland

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NCT05796973


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