Effectiveness of an Individualized Program of Muscular Strength and Endurance Program for Improving Germ Cell Cancer

Study Overview
=================
Brief Summary
-----------------
Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with GCC undergoing treatment with chemotherapy. Although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited. Methods/Design: The present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. All variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. Besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

Detailed Description
-----------------
Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with GCC undergoing treatment with chemotherapy. Although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited. Our aim is to evaluate the effects of an individualized exercise program with aerobic training in water running on cancer-related fatigue. Methods/Design: The present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. The investigators will conduct this trial in patients undergoing chemotherapy, recruited by the Departament of Oncology of Virgen de la Victoria Hospital (Málaga). Patients will be included and evaluated before the first cycle of chemotherapy and assigned experimental or control group randomly. All variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. Besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

Official Title
-----------------
Effectiveness of an Individualized Program of Muscular Strength and Endurance Program With Aerobic Training for Improving Germ Cell Cancer Related Fatigue in Men Undergoing Chemotherapy

Conditions
-----------------
Testicular Germ Cell Cancer

Intervention / Treatment
-----------------
* Device: Aerobic program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients programmed to chemotherapy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic program<br>Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. | Device: Aerobic program<br>* The intervention will be an 8-week program of individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. Each program will be individualized based on the evaluations of muscular strength and enduranceas well as determination of aerobic-anaerobic zone transition described in previous studies In sessions of one hour 3 times a week. Each session will consist of 30 minutes of exercises performed on land followed by 20 minutes of continuous running in treadmill. In week 1 and 2 participants carry out 3 sets of 15 repetitions (reps) to become familiar with the exercises. From week 3 onwards participants will perform 4 sets of 10 reps. If the participant can do more than 12 reps, weight will be increased. All exercises are conducted supervised to ensure proper technique and adequate progression.<br>|
| No Intervention: Control group<br>They will be instructed to continue their current activities and not to increase objectively levels of physical activity performed during the 8-week intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue QuickPiper scale | The primary outcome will be fatigue, assessed by the revised Cancer-related fatigue QuickPiper scale, with the semi-structured interview used by Cella et al (1998) to define phenotype of CRF | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sf-12 | The state of physical and mental health | 10 min | 
| EuroQoL-5D | Quality of life | 10 min | 
| Profile of Mood States | It is possible to obtain an overall index of altered mood and seven partial measures: stress / anxiety, depression / rejection, anger / hostility, vigor / activity, fatigue / inertia and confusion / bewilderment | 10 min | 
| Physical condition test | strength peak of knee extension (quadriceps), knee flexion (hamstring), elbow extension (brachial triceps) and elbow flexion (biceps brachii) by one dynamometry instrumented with Powertruck II of JTECH, following the protocol described by Daniels & Worthingham (1995). Hand grip strength will be evaluated by the hydraulic dynamometer JAMAR | 20 min | 
| C-reactive protein (CRP) | It will be measured in blood samples following clinical standards in 10 ml venous blood | 20 min | 
| Tumor Necrosis Factor alpha (TNF-a) | It will be measured in blood samples following clinical standards in 10 ml venous blood sample. | 20 min | 
| Interleukin-6 (IL-6), Interleukin-18 (IL-18), Interleukin-4 (IL-4) and Interleukin-10 (IL 10) | It will be measured in blood samples following clinical standards in 10 ml venous blood | 20 min | 
| high density lipoprotein (HDL), low density lipoprotein (LDL) cholesterol, triglycerides | It will be measured in blood samples following clinical standards in 10 ml venous blood | 20 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Testicular cancer, Germ cell cancer, Physical exercise, Cancer-related fatigue, Chemotherapy, Clinical rules, Metabolomics