Progressive Resistance Training and Cancer Testis (PROTRACT) - the effect of chemotherapy on the skeletal musculature in testicular cancer patients
| ISRCTN | ISRCTN32132990 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32132990 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/03/2011
- Registration date
- 25/03/2011
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Jesper Frank Christensen
Scientific
Scientific
UCSF
Rigshospitalet, afsnit 7331
Blegdamsvej 9
Copenhagen
2100
Denmark
| jfc@rh.regionh.dk |
Study information
| Study design | Randomised single-blinded single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a a patient information sheet |
| Scientific title | Progressive Resistance Training and Cancer Testis (PROTRACT) - Efficacy of resistance training on muscle function, morphology and inflammation in testicular cancer patients undergoing chemotherapy |
| Study acronym | PROTRACT |
| Study hypothesis | 1. Testicular cancer patients (TCP) undergoing chemotherapy with cisplatin, etoposide and bleomycin (BEP-treatment) experience: 1.1. Impaired muscular function and reduced lean body mass, but high intentity progressive resistance training (HIPRT) initiated early in the course of treatment can reverse this impairment 1.2. Muscular atrophy, which can be reduced by HIPRT. The potential for muscular hypertrophy is attenuated in TCP compared to a healthy control group 1.3. Increased systemic and local inflammation, which can contribute to the muscular deconditioning, compared to a healthy control group |
| Ethics approval(s) | 1. Scientific Committees of the Copenhagen and Frederiksberg Municipalities (j.no. H-1-2010-049) approved on 28th February 2011 2. Danish Data Protection Agency (j.no. 2010-41-5118) |
| Condition | Testicular Cancer |
| Intervention | High intensity progressive resistance training 3 times per week . 1. The STR group will receive a 9 week intervention period during the entire course of BEP treatment, followed by a 12 week training period after the course of treatment. 2. The UNT group will receive usual care for 9 weeks during the entire course of BEP treatment, bur will recieve a 12 week training period after the course of treatment 3. The CON group will receive a 21 week training period |
| Intervention type | Other |
| Primary outcome measure | Cellular muscle morphology will be assesed by muscle biopsies collected from m. vastus lateralis using the Bergstrom-technique. Muscle mean fibre area and fibre type distribution will be analysed by ATPase histo-chemistry. The outcomes will be measured on the following time points Baseline, before 1. cycle (0 weeks): Biopsy, Dual-emission X-ray absorptiometry (DXA) scan, strength test, blood sample, questionairres Before 2. cycle (3 weeks): blood sample, questionairres Before 3. cycle (6 weeks): blood sample, questionairres Post treatment (9 weeks): biopsy, DXA scan, strength test, blood sample, questionairres Follow up (21 weeks): DXA scan, strength test, blood sample, questionairres |
| Secondary outcome measures | 1. Satellite cells and intracelluar signaling molecules. Muscle biopsies are analysed for number and activation of satellite cells by immunohistochemistry and levels of protein and mRNA expression of insulin-like growth factor-1 (IGF-1) and myostatin are analysed by Western blotting and real time-polymerase chain reaction (PCR) assays respectively 2. Physical function tests- Maximum isometric quadriceps muscle strength is assessed by maximum voluntary contraction (MVC)-measurements using Good Strength-chair and maximum muscle power are evaluated by Leg Extensor Power (LEP)-measurements in Power-Rig 3. Whole Body composition including lean body mass are analysed by whole body dual-energy X-ray absorptiometry (DXA scan) 4. Systemic inflammation, lipid and glucose metabolism are evaluated by fasting blood samples. 10 ml EDTA blood samples will be taken and analysed using the enzyme-linked immunosorbent assay (ELISA)- technique for levels of circulating cytokines [C-reactive protein (CRP), tumor necrosis factor (TNF)-alpha, Interleukin (IL-6, IL-18, IL-4, IL-10)], lipid and glucose metabolism [total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, glucose and insulin] 5. Patient reported outcomes will include standardised questionaires to evaluate health related Quality of Life (QoL) by Short Form-36 (SF-36) and EORTC QLQ-C30 |
| Overall study start date | 01/01/2011 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Male |
| Target number of participants | 45 |
| Participant inclusion criteria | Testicular cancer patients (TCP), age 18-45, with advanced disease who are scheduled to start 3 cycles of BEP-treatment |
| Participant exclusion criteria | 1. Other previous or concurrent malignant disease 2. Cardiovascular disease 3. Chronic disease (ie. Diabetes) 4. Hypogonadism |
| Recruitment start date | 01/01/2011 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- Denmark
Study participating centre
UCSF
Copenhagen
2100
Denmark
2100
Denmark
Sponsor information
The Faculty of Health Sciences, Copenhagen University (Denmark)
University/education
University/education
Blegdamsvej 3B
Copenhagen
2200
Denmark
"ROR" |
https://ror.org/035b05819 |
|---|
Funders
Funder type
Other
Faculty of Health Science, University of Copenhagen (Denmark)
No information available
Centre of Integrated Rehabilitation of Cancer Patients (CIRE) (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/08/2011 | Yes | No | |
| Results article | results | 08/07/2014 | Yes | No |
Editorial Notes
02/10/2017: Publication reference added.
