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
Protocol serial number	N/A
Sponsor	The Faculty of Health Sciences, Copenhagen University (Denmark)
Funders	Faculty of Health Science, University of Copenhagen (Denmark), Centre of Integrated Rehabilitation of Cancer Patients (CIRE) (Denmark)

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 of protocol

Not provided at time of registration

Contact information

Mr Jesper Frank Christensen
Scientific

UCSF
Rigshospitalet, afsnit 7331
Blegdamsvej 9
Copenhagen
2100
Denmark

Email	jfc@rh.regionh.dk

Study information

Primary study design	Interventional
Study design	Randomised single-blinded single-centre study
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion 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 sample size at registration	45
Key inclusion criteria	Testicular cancer patients (TCP), age 18-45, with advanced disease who are scheduled to start 3 cycles of BEP-treatment
Key exclusion criteria	1. Other previous or concurrent malignant disease 2. Cardiovascular disease 3. Chronic disease (ie. Diabetes) 4. Hypogonadism
Date of first enrolment	01/01/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Denmark

Study participating centre

UCSF

Copenhagen
2100
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/07/2014		Yes	No
Protocol article	protocol	01/08/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

02/10/2017: Publication reference added.