Testicular CancerNCT01749774
Physical Activity and Testicular Cancer
A study testing Physical activity counseling in people with Testicular Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2012to Jun 2013
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seminoma/non-seminoma
- Stage II-IV
- 3-4 BEP(bleomycin,etoposide and cisplatin)or 4 EP(etoposide and cisplatin)
- > 18 years
- Capable of reading and writing Norwegian
Who cannot join
- Conditions of a severity that contraindicate exercise without adjusted actions
- Mentally incompetent conditions
- Conditions of a severity that complicates the ability to participate in a supervised training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Testicular Cancer - a Pilot Study: Feasibility and Effects of a Program Including Information, Counseling and a Physical Activity Program for Patients With Testicular Cancer During and After Chemotherapy
The purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. It is hypothesized that the patients are able to complete the intervention with individual adjustments.
- Conditions
- Testicular Cancer
- Being tested
- Physical activity counseling
- Keywords
- Physical activity, Testicular cancer, Chemotherapy, Feasibility
- 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.
Physical activity counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Physical activity counseling | Experimental | Not described Receives: Behavioral: Physical activity counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength, 1RM (one-repetition-maximum)
Change in 1RM from baseline to post-intervention and follow-up
Measured: Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)
Secondary outcomes (11)
Cardio respiratory fitness (VO2max)
Change in VO2max from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Body composition (Lean body mass and fat mass)
Change in body composition from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Metabolic disease markers (blood pressure, body mass index, glucose, high density lipoprotein cholesterol, triglycerides)
Change in metabolic disease markers from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
C-reactive protein (CRP)
Change in CRP from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Creatinkinase (CK)
Change in CK from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Creatinkinase - MB (CK-MB)
Change in CK-MB from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Myoglobin
Change in myoglobin from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Work status
Change in work status from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Fatigue
Change in fatigue from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Anxiety and depression
Change in anxiety and depression from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Quality of life
Change in quality of life from baseline to post-intervention and follow-up
Measured: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
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 CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Gjensidigestiftelsen, The Research Council of Norway
- Responsible party
- Principal investigator, Lene Thorsen, Oslo University Hospital
- Investigators
- Lene Thorsen, PhD, Principal investigator, Oslo universty hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749774
- Sponsor's protocol ID
- 2011/2008a
- Status last verified
- Oct 2014
- First submitted
- 30 Nov 2012
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thorsen L, Kirkegaard C, Loge JH, Kiserud CE, Johansen ML, Gjerset GM, Edvardsen E, Hamre H, Ikdahl T, Fossa SD. Feasibility of a physical activity intervention during and shortly after chemotherapy for testicular cancer. BMC Res Notes. 2017 Jun 15;10(1):214. doi: 10.1186/s13104-017-2531-y.
PubMed 28619116
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Testicular Cancer - a Pilot Study: Feasibility and Effects of a Program Including Information, Counseling and a Physical Activity Program for Patients With Testicular Cancer During and After Chemotherapy
- ClinicalTrials.gov ID
- NCT01749774
- Acronym / sponsor ID
- 2011/2008a
- Conditions
- Testicular Cancer
- Keywords
- Physical activity, Testicular cancer, Chemotherapy, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Gjensidigestiftelsen, The Research Council of Norway
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2012 (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 purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. It is hypothesized that the patients are able to complete the intervention with individual adjustments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity counseling | Experimental | Behavioral: Physical activity counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Seminoma/non-seminoma
- Stage II-IV
- 3-4 BEP(bleomycin,etoposide and cisplatin)or 4 EP(etoposide and cisplatin)
- > 18 years
- Capable of reading and writing Norwegian
Key exclusion criteria (3 listed)
- Conditions of a severity that contraindicate exercise without adjusted actions
- Mentally incompetent conditions
- Conditions of a severity that complicates the ability to participate in a supervised training 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 |
|---|---|---|
| Physical activity counseling | Behavioural | Physical activity counseling |
Primary outcome
Muscle strength, 1RM (one-repetition-maximum)
Time frame: Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)
Change in 1RM from baseline to post-intervention and follow-up
11 secondary outcomes
Cardio respiratory fitness (VO2max)
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Body composition (Lean body mass and fat mass)
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Metabolic disease markers (blood pressure, body mass index, glucose, high density lipoprotein cholesterol, triglycerides)
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
C-reactive protein (CRP)
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Creatinkinase (CK)
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Creatinkinase - MB (CK-MB)
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Myoglobin
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Work status
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Fatigue
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Anxiety and depression
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Quality of life
Time frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
- Derived from this study: PubMed 28619116Thorsen L, Kirkegaard C, Loge JH, Kiserud CE, Johansen ML, Gjerset GM, Edvardsen E, Hamre H, Ikdahl T, Fossa SD. Feasibility of a physical activity intervention during and shortly after chemotherapy for testicular cancer. BMC Res Notes. 2017 Jun 15;10(1):214. doi: 10.1186/s13104-017-2531-y.
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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 universty 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 Physical activity counseling in people with Testicular Cancer, 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: finished, as of the sponsor's last update on 16 Oct 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle strength, 1RM (one-repetition-maximum) (time frame: Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)). 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 NCT01749774, 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 16 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.