Measuring Oncological Value of Exercise and Statin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guided physical exercise, Atorvastatin, Independent exercise.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Breast Cancer, Kidney Cancer, Ovarian Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Syöpäpotilaan Ennusteen Parantaminen Muuttamalla syövän mikroympäristöä ja Metaboliaa Liikunnalla ja lääkkeellisesti - Measuring Oncological Value of Exercise and Statin
Overview
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.
Interventions
- Behavioral 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. - Drug 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. - Other 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.
Primary outcome measures
- Time to cancer progression [Time frame: From randomization until the date of first documented progression, assessed at twelve week intervals up to 24 months]
- Mortality [Time frame: From randomization until the date of death, assessed up to 24 months]
Secondary outcome measures (10)
- Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH) [Time frame: At baseline and at 3 months]
- Tolerability of treatment [Time frame: From date of randomization, assessed at twelve week intervals up to 24 months]
- Fat/muscle ratio as measured with impedance test [Time frame: At baseline and at 3 and 6 months]
- Physical performance with standardized muscle strength tests [Time frame: At baseline and at 3 and 6 months]
- Changes in tissue hypoxia [Time frame: At baseline and at 3 months]
- Changes in quality of life [Time frame: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months]
- Depressive symptoms [Time frame: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months]
- Severity of pain [Time frame: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months]
- Nutritional status [Time frame: At baseline and at 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months]
- Relationship satisfaction [Time frame: At baseline and at three months, twelve months and 24 moths.]
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)
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Tampere University Hospital — Tampere
Identifiers
NCT: NCT05796973 · 2019-001982-34