Metastatic breast, ovarian, kidney and prostate cancer MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10057529
Conditions
Interventions
Trade Name: Atorvastatin 40 mg, saatavuuden mukaan kauppanimeä voidaan joutua vaihtamaan tutkimuksen kuluessa.
Pharmaceutical Form: Tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523-00-5
Sponsors
Pirkanmaan hyvinvointialue
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically and imaging confirmed metastatic breast, ovarian, kidney or prostate cancer in which first line treatment is given 2) Signed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: 1. High risk for bone fracture 2. Inability for physical exercise and/or inability for cancer treatments 3. Poor co-operation for psychological reason 4. Current use of cholesterol-lowering drugs 5. Severe liver or renal impairment 6. Previous side-effect of cholesterol-lowering medication 7. Current use of drugs with known interact with atorvastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to investigate if supervised group exercise will improve response to cancer treatments in metastasized breast, kidney, prostate, and ovarian cancer compared to unsupervised exercise and also evaluate if atorvastatin treatment in combination with guided group exercise can promote even better treatment responses than exercise alone. ;Secondary Objective: Impact of exercise, cancer treatment, and side-effects on quality of life, depression symptoms, and relationship;Primary end point(s): Cancer progression despite of treatment or death;Timepoint(s) of evaluation of this end point: FU visits every 3 month during 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Serum levels of hypoxia markers VEGF, canonic anhydrase IX, LADH, amd HIF1a 2. Side-effects of treatments 3. Body consumption before and after intervention 4. Performance status before and after intervention 5. Amount of hypoxia in tumors based on PET/CT imaging 6. Quality of life, depression symptoms, and relationship;Timepoint(s) of evaluation of this end point: Follow-up visits in 3 months interval for 2 years | — |
Countries
Finland
Contacts
Public ContactTeemu Murtola
Pirkanmaan sairaanhoitopiiri
Outcome results
None listed