Physical Activity and Testicular Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. It is hypothesized that the patients are able to complete the intervention with individual adjustments.

Official Title
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Physical Activity and Testicular Cancer - a Pilot Study: Feasibility and Effects of a Program Including Information, Counseling and a Physical Activity Program for Patients With Testicular Cancer During and After Chemotherapy

Conditions
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Testicular Cancer

Intervention / Treatment
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* Behavioral: Physical activity counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seminoma/non-seminoma Stage II-IV 3-4 BEP(bleomycin,etoposide and cisplatin)or 4 EP(etoposide and cisplatin) > 18 years Capable of reading and writing Norwegian Exclusion Criteria: Conditions of a severity that contraindicate exercise without adjusted actions Mentally incompetent conditions Conditions of a severity that complicates the ability to participate in a supervised training program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity counseling<br> | Behavioral: Physical activity counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength, 1RM (one-repetition-maximum) | Change in 1RM from baseline to post-intervention and follow-up | Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio respiratory fitness (VO2max) | Change in VO2max from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Body composition (Lean body mass and fat mass) | Change in body composition from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Metabolic disease markers (blood pressure, body mass index, glucose, high density lipoprotein cholesterol, triglycerides) | Change in metabolic disease markers from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| C-reactive protein (CRP) | Change in CRP from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Creatinkinase (CK) | Change in CK from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Creatinkinase - MB (CK-MB) | Change in CK-MB from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Myoglobin | Change in myoglobin from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Work status | Change in work status from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Fatigue | Change in fatigue from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Anxiety and depression | Change in anxiety and depression from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 
| Quality of life | Change in quality of life from baseline to post-intervention and follow-up | Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility, Physical activity, Testicular cancer, Chemotherapy