Overview
Sponsor-declared trial summary
Metastatic breast, ovarian, prostate and kidney cancer
1) Whether supervised group exercise with aerobic and resistance training during anticancer therapy improves the efficacy of anticancer therapy in advanced breast, renal, ovarian, and prostate cancer compared with self-administered exercise and whether the use of atorvastatin combined with supervised group exercise fur…
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 31 Mar 2023 → ongoing
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515109-24-00
- EudraCT number
- 2019-001982-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
1) Whether supervised group exercise with aerobic and resistance training during anticancer therapy improves the efficacy of anticancer therapy in advanced breast, renal, ovarian, and prostate cancer compared with self-administered exercise and whether the use of atorvastatin combined with supervised group exercise further improves the response to cancer treatment.
Secondary objectives 1
- 1. Whether exercise alone reduces hypoxia sufficiently to improve the efficacy of chemotherapy as a cancer treatment and whether inhibition of lipid synthesis with statins enhances this effect. Each of these cancers is characterised by a hypoxic microenvironment. In addition, each type of cancer is characterised by lipid accumulation, suggesting the importance of this feature as a means of coping with hypoxia. 2. To explore patients' experiences of the impact of cancer treatment, its side effects and increased physical activity on their quality of life, depressive symptoms, pain, diet and relationships
Conditions and MedDRA coding
Metastatic breast, ovarian, prostate and kidney cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10055113 | Breast cancer metastatic | 100000004864 |
| 20.1 | LLT | 10023400 | Kidney cancer | 10029104 |
| 27.0 | PT | 10057529 | Ovarian cancer metastatic | 100000004864 |
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) Patients with histologically and imaging confirmed metastatic prostate, breast, ovarian or renal cancer for which 1st line anticancer therapy is being initiated. 2) The patient consents to the study and signs a written informed consent. 3) Women (breast, ovarian and renal cancer) and men (prostate and renal cancer) of legal age (18 years =>) are recruited. 4) Women will use a reliable method of contraception during the trial.
Exclusion criteria 1
- All patients: 1. High fracture risk 2. Unable to exercise and/or unable to receive anticancer therapy 3. Psychologically uncooperative 4. Severe liver or kidney failure 5. Special category of subjects under the Medical Research Act (1999/488) (e.g. minors and pregnant or breastfeeding women). In addition to excl. criteria for patients who were not on statin medication at the start of the study: Active use of cholesterol-lowering drugs, A history of serious side effects from cholesterol-lowering drugs and Continued use of drugs that interact with atorvastatin during the period of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Cancer progression (based on radiological, biochemical or clinical evaluation) and mortality (evaluated by time from starting 1. line cancer treatment to death)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Lipistad 40 mg kalvopäällysteiset tabletit
PRD3807142 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 32734
- MA holder
- STADA ARZNEIMITTEL AG
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pirkanmaan hyvinvointialue
- Sponsor organisation
- Pirkanmaan hyvinvointialue
- Address
- Elamanaukio 2
- City
- Tampere
- Postcode
- 33520
- Country
- Finland
Scientific contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Teemu Murtola
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Teemu Murtola
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 240 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2023-03-31 | 2023-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D4_Brief pain questionnaire Finnish | 1 |
| Protocol (for publication) | D4_MNA questionnaire | 1 |
| Protocol (for publication) | D4_Parisuhdekysely | 1 |
| Protocol (for publication) | D4_PHQ9 | 1 |
| Protocol (for publication) | D4_QLQ-C30Finnish | 3 |
| Protocol (for publication) | MOVES Protocol | 8.2 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF finnish Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF swedish Redacted | 4 |
| Subject information and informed consent form (for publication) | L1:SIS and ICF english Redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Lipistad_valmisteyhteenveto | 1 |
| Synopsis of the protocol (for publication) | MOVES tutkimussuunnitelman yhteenveto | 4 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-06 | Finland | Acceptable with conditions 2024-08-19
|
2024-08-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-16 | Finland | Acceptable 2025-06-01
|
2025-06-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | Finland | Acceptable 2025-06-01
|
2025-09-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-02 | Finland | Acceptable 2025-06-01
|
2026-03-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-21 | Finland | Acceptable 2025-06-01
|
2026-05-21 |