Testicular Cancer and Aerobic and Strength Training (TAST)

January 25, 2017 updated by: Lene Thorsen, Oslo University Hospital

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

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.

Study Overview

Status

Terminated

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

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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.

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)
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)
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
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)
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
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)
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.
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
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
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)
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.
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
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.
Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
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.
Pre-intervention (week 0) to post-intervention (week 10/13)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lene Thorsen, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Testicular Neoplasms

Clinical Trials on Exercise group

3
Subscribe