Testicular Neoplasms Clinical Trial
— TASTOfficial title:
Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study
Verified date | January 2017 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Norwegian School of Sport Sciences |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Safety and tolerability | Number of participants with adverse events during the exercise intervention. | Pre-intervention (week 0) to post-intervention (week 10/13) |
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