Progressive Resistance Training and Cancer Testis (PROTRACT) - the effect of chemotherapy on the skeletal musculature in testicular cancer patients

Progressive Resistance Training and Cancer Testis (PROTRACT) - Efficacy of resistance training on muscle function, morphology and inflammation in testicular cancer patients undergoing chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32132990

Enrollment

Registered

2011-03-25

Start date

2011-01-01

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Cancer Cancer Malignant neoplasm of testis

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Other previous or concurrent malignant disease 2. Cardiovascular disease 3. Chronic disease (ie. Diabetes) 4. Hypogonadism

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026