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Physical Activity and Testicular Cancer

This study is currently recruiting participants.
Verified December 2012 by Oslo University Hospital
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
Aktiv against cancer
Gjensidigestiftelsen
The Research Council of Norway
Information provided by (Responsible Party):
Lene Thorsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01749774
First received: November 30, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Testicular Cancer
 Behavioral: Physical activity counseling

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Muscle strength, 1RM (one-repetition-maximum) [ Time Frame: Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in 1RM from baseline to post-intervention and follow-up


Secondary Outcome Measures:
  • Cardio respiratory fitness (VO2max) [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in VO2max from baseline to post-intervention and follow-up

  • Body composition (Lean body mass and fat mass) [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in body composition from baseline to post-intervention and follow-up

  • 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) ] [ Designated as safety issue: No ]
    Change in metabolic disease markers from baseline to post-intervention and follow-up

  • C-reactive protein (CRP) [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in CRP from baseline to post-intervention and follow-up

  • Creatinkinase (CK) [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in CK from baseline to post-intervention and follow-up

  • Creatinkinase - MB (CK-MB) [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in CK-MB from baseline to post-intervention and follow-up

  • Myoglobin [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in myoglobin from baseline to post-intervention and follow-up

  • Work status [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in work status from baseline to post-intervention and follow-up

  • Fatigue [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in fatigue from baseline to post-intervention and follow-up

  • Anxiety and depression [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in anxiety and depression from baseline to post-intervention and follow-up

  • Quality of life [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ] [ Designated as safety issue: No ]
    Change in quality of life from baseline to post-intervention and follow-up


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity counseling Behavioral: Physical activity counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749774

Contacts
Contact: Lene Thorsen, PhD 004722934000 LKA@ous-hf.no
Contact: Jon Håvard Loge, Prof. 004722934000 jonlog@ous-hf.no

Locations
Norway
Oslo university hospital Recruiting
Oslo, Norway
Contact: Lene Thorsen, PhD         LKA@ous-hf.no    
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
Aktiv against cancer
Gjensidigestiftelsen
The Research Council of Norway
Investigators
Principal Investigator: Lene Thorsen, PhD Oslo universty hospital
  More Information

No publications provided

Responsible Party: Lene Thorsen, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01749774     History of Changes
Other Study ID Numbers: 2011/2008a
Study First Received: November 30, 2012
Last Updated: December 12, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Physical activity
Testicular cancer
Chemotherapy
Feasibility

Additional relevant MeSH terms:
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
 Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on June 17, 2013