Condition category
Cancer
Date applied
08/03/2011
Date assigned
25/03/2011
Last edited
10/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jesper Frank Christensen

ORCID ID

Contact details

UCSF
Rigshospitalet
afsnit 7331
Blegdamsvej 9
Copenhagen
2100
Denmark
jfc@rh.regionh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

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)

Study design

Randomised single-blinded single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Testicular cancer patients (TCP), age 18-45, with advanced disease who are scheduled to start 3 cycles of BEP-treatment

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

45

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

Trial participating centre

UCSF
Copenhagen
2100
Denmark

Sponsor information

Organisation

The Faculty of Health Sciences, Copenhagen University (Denmark)

Sponsor details

Blegdamsvej 3B
Copenhagen
2200
Denmark

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Faculty of Health Science, University of Copenhagen (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Centre of Integrated Rehabilitation of Cancer Patients (CIRE) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 study design in http://www.ncbi.nlm.nih.gov/pubmed/21806789

Publication citations

  1. Study design

    Christensen JF, Andersen JL, Adamsen L, Lindegaard B, Mackey AL, Nielsen RH, Rørth M, Daugaard G, Progressive resistance training and cancer testis (PROTRACT) - efficacy of resistance training on muscle function, morphology and inflammatory profile in testicular cancer patients undergoing chemotherapy: design of a randomized controlled trial., BMC Cancer, 2011, 11, 326, doi: 10.1186/1471-2407-11-326.

Additional files

Editorial Notes