Testicular Cancer and Aerobic and Strength Training

Study Overview
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Brief Summary
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The present study examine the effects of an aerobic and strength training program on cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the participants will receive the exercise program and the other half will receive one individual lifestyle counseling session. The investigators hypothesize that TC patients in the exercise group will have less reduction in cardiorespiratory fitness during chemotherapy treatment compared to patients in the control group.

Detailed Description
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Testicular cancer (TC) patients receiving chemotherapy often experience troublesome side-effects during and after treatment. Both aerobic and strength exercise have showed beneficial effects on side-effects during and after treatment in other cancer diagnosis. Knowledge of the effects of physical exercise during and after chemotherapy in TC patients is insufficient and studies are needed. The primary aim is to examine the effects of physical exercise on cardiorespiratory fitness in TC patients during chemotherapy. Secondary aims are to examine the effects of physical exercise on other secondary health outcomes during and three and twelve months after chemotherapy. The present study is a randomized controlled trial comparing a tailored exercise program consisting of aerobic and strength training during chemotherapy to a control group receiving one individual lifestyle counseling session during the first chemotherapy cycle. The TC patients will be included and assessed before the first cycle of chemotherapy and further assigned to either a exercise group or a control group. The intervention will last for 9 or 12 weeks (depending on the number of bleomycin, etoposide, cisplatin (BEP)/etoposide, cisplatin (EP) cycles received) and it will consists of two-three one-hour sessions per week mostly supervised by a personal trainer. All variables will be assessed pre- and post-intervention, and at three and 12 months follow-up.

Official Title
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Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study

Conditions
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Testicular Neoplasms

Intervention / Treatment
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* Behavioral: Exercise group
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: testicular cancer with seminoma or non-seminoma stage II-IV referred to chemotherapy (3-4 BEP (bleomycin, etoposide and cisplatin)-cycles or 4 EP (etoposide and cisplatin) -cycles) with/without retroperitoneal lymph node dissection (RPLND) satisfactory Norwegian Language skills signed informed consent Exclusion Criteria: severe brain and lung metastasis (reduced lung function) heart and lung diseases that contraindicate exercise testing and the supervised exercise program without adjusted actions according to American College of Sports Medicine (ACSM)'s guidelines) physical and mental conditions of a severity that complicates the ability for exercise testing and the supervised exercise program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Aerobic- and Strength Training program | Behavioral: Exercise group<br>* The intervention will be conducted during chemotherapy and tailored for each patient. The program will include 1) weight bearing aerobic exercises to maintain the oxygen transport and thereby reduce the decline in VO2max during chemotherapy and 2) strength training exercises to maintain muscle mass and muscle strength. The intervention will last for 9 or 12 weeks, depending on the number of BEP/EP cycles received. The program will consist of two-three one-hour exercise sessions per week, of which most supervised by a personal trainer. The intensity of each exercise sessions will varies from easy (warm-up: 60-70 % of peak heart rate) to moderate/high (between aerobic intervals 60-70% of peak heart rate and during aerobic intervals 85-95 %).<br>|
| Active Comparator: Control group<br>One lifestyle counseling session | Behavioral: Control group<br>* The control group will receive one individual lifestyle counseling session during the first chemotherapy cycle and can perform all activities that they have planned to do during chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak (directly by modified Balke protocol on a treadmill) | Differences in change in VO2peak from pre- to post-intervention between the exercise group and the control group. | Pre-intervention (week 0) to post-intervention (week 10/13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak (directly by modified Balke protocol on a treadmill) | Differences in change in VO2peak from pre-post-intervention to three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of reduced VO2peak at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Spirometry | Differences in change in pulmonary function (lung capacity, lung volume, diffusion capacity) from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| One-repetition maximum muscle strength test (1RM) | Differences in change in muscle strength from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Dual-energy X-ray absorptiometry (DXA) | Differences in change in lean body mass and fat mass from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of unhealthy body composition at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Body mass index (BMI) | Differences in change in BMI from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of unhealthy BMI at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Hip- and Waist circumferences | Differences in change in hip- and waist circumferences from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Godin Leisure Time Exercise Questionnaire (GLTEQ) | Differences in change in physical exercise from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of being inactive at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Sick leave and Work Ability Index (WAI) | Differences in work ability and sick leave from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of reduced work ability at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C-30 | Differences in change in health related quality of life (HRQOL) from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of having reduced HRQOL at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Fatigue questionnaire | Differences in change in fatigue from pre- to post-intervention and at three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of having fatigue at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Hospital and Anxiety and Depression Scale (HADS) | Differences in change in anxiety and depression from pre- to post-intervention and to three and 12 months follow-ups between the exercise group and the control group. Examine potential prognostic factors of having anxiety and depression at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Markers for inflammation, endothelia dysfunction, thrombosis and cardiovascular diseases and cisplatin | Differences in change in blood tests from pre- to post intervention and at three and 12 months follow-up in the exercise group and the control group. Examine potential risk factors for endothelia dysfunction, activated coagulation and thrombosis and cardiovascular diseases (metabolic syndrome) at 12 months follow-up in all participants. | Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups | 
| Safety and tolerability | Number of participants with adverse events during the exercise intervention. | Pre-intervention (week 0) to post-intervention (week 10/13) | 

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