- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577172
Testicular Cancer and Aerobic and Strength Training (TAST)
Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oslo, Norway
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
Aerobic- and Strength Training program
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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 %).
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Active Comparator: Control group
One lifestyle counseling session
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2peak (directly by modified Balke protocol on a treadmill)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13)
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Differences in change in VO2peak from pre- to post-intervention between the exercise group and the control group.
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Pre-intervention (week 0) to post-intervention (week 10/13)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2peak (directly by modified Balke protocol on a treadmill)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Spirometry
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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One-repetition maximum muscle strength test (1RM)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Dual-energy X-ray absorptiometry (DXA)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Body mass index (BMI)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Hip- and Waist circumferences
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Godin Leisure Time Exercise Questionnaire (GLTEQ)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Sick leave and Work Ability Index (WAI)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C-30
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Fatigue questionnaire
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Hospital and Anxiety and Depression Scale (HADS)
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Markers for inflammation, endothelia dysfunction, thrombosis and cardiovascular diseases and cisplatin
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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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.
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Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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Safety and tolerability
Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13)
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Number of participants with adverse events during the exercise intervention.
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Pre-intervention (week 0) to post-intervention (week 10/13)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lene Thorsen, PhD, Oslo University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK - 2014/1169
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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