Testicular NeoplasmsTASTNCT02577172
Testicular Cancer and Aerobic and Strength Training
A study testing Exercise group in people with Testicular Neoplasms, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Testicular Neoplasms
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Testicular Neoplasms
- Being tested
- Exercise group, Control group
- Keywords
- Testicular cancer, Physical Exercise, Chemotherapy
- Medical subject headings
- Testicular Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
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 %).
Control groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Aerobic- and Strength Training program Receives: Behavioral: Exercise group |
| Control group | Active comparator | One lifestyle counseling session Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention (week 0) to post-intervention (week 10/13)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention (week 0) to post-intervention (week 10/13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Unexpected events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular NeoplasmsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Lene Thorsen, Oslo University Hospital
- Investigators
- Lene Thorsen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577172
- Sponsor's protocol ID
- REK - 2014/1169
- Acronym
- TAST
- Status last verified
- Jan 2017
- First submitted
- 8 Oct 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thorsen L, Haugnes HS, Fossa SD, Brydoy M, Tandstad T, Wisloff T, Gjerset GM, Edvardsen E, Larsen KO, Sandset PM, Henriksson CE, Raastad T, Negaard HFS. Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature. Int J Cancer. 2020 Dec 1;147(11):3189-3198. doi: 10.1002/ijc.33151. Epub 2020 Jul 1.
PubMed 32525564
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study
- ClinicalTrials.gov ID
- NCT02577172
- Acronym / sponsor ID
- TAST / REK - 2014/1169
- Conditions
- Testicular Neoplasms
- Keywords
- Testicular cancer, Physical Exercise, Chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unexpected events
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise groupAerobic- and Strength Training program |
| Control group | Active comparator | Behavioral: Control groupOne lifestyle counseling session |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise groupThe 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 %). | Behavioural | Exercise group |
| Control groupThe 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. | Behavioural | Control group |
Primary outcome
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.
13 secondary outcomes
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
Spirometry
Time frame: 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
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
Body mass index (BMI)
Time frame: 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
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
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
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
Fatigue questionnaire
Time frame: 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
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
Safety and tolerability
Time frame: Pre-intervention (week 0) to post-intervention (week 10/13)
Results and safety
The study was stopped early (reason given: Unexpected events). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 32525564Thorsen L, Haugnes HS, Fossa SD, Brydoy M, Tandstad T, Wisloff T, Gjerset GM, Edvardsen E, Larsen KO, Sandset PM, Henriksson CE, Raastad T, Negaard HFS. Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature. Int J Cancer. 2020 Dec 1;147(11):3189-3198. doi: 10.1002/ijc.33151. Epub 2020 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Thorsen, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Testicular Neoplasms, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unexpected events). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (directly by modified Balke protocol on a treadmill) (time frame: Pre-intervention (week 0) to post-intervention (week 10/13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.