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Testicular Cancer and Aerobic and Strength Training (TAST)

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ClinicalTrials.gov Identifier: NCT02577172
Recruitment Status : Terminated (Unexpected events)
First Posted : October 16, 2015
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Lene Thorsen, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Testicular Neoplasms Behavioral: Exercise group Behavioral: Control group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise group
Aerobic- and Strength Training program
Behavioral: Exercise group
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 %).

Active Comparator: Control group
One lifestyle counseling session
Behavioral: Control group
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.




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


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Spirometry [ Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. Body mass index (BMI) [ Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups ]
    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.

  6. Hip- and Waist circumferences [ Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.

  10. Fatigue questionnaire [ Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups ]
    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.

  11. 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 ]
    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.

  12. 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 ]
    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.

  13. Safety and tolerability [ Time Frame: Pre-intervention (week 0) to post-intervention (week 10/13) ]
    Number of participants with adverse events during the exercise intervention.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577172


Locations
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Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
Investigators
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Principal Investigator: Lene Thorsen, PhD Oslo University Hospital

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Responsible Party: Lene Thorsen, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02577172     History of Changes
Other Study ID Numbers: REK - 2014/1169
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lene Thorsen, Oslo University Hospital:
Testicular cancer
Physical Exercise
Chemotherapy
Additional relevant MeSH terms:
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Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders