Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Activity and Testicular Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01749774
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : October 16, 2014
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
Gjensidigestiftelsen
The Research Council of Norway
Information provided by (Responsible Party):
Lene Thorsen, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 17, 2012
Last Update Posted Date October 16, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01749774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
  • Cardio respiratory fitness (VO2max) [ Time Frame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    Change in quality of life from baseline to post-intervention and follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity and Testicular Cancer
Official Title  ICMJE 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
Brief 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. It is hypothesized that the patients are able to complete the intervention with individual adjustments.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Testicular Cancer
Intervention  ICMJE Behavioral: Physical activity counseling
Study Arms  ICMJE Experimental: Physical activity counseling
Intervention: Behavioral: Physical activity counseling
Publications * Thorsen L, Kirkegaard C, Loge JH, Kiserud CE, Johansen ML, Gjerset GM, Edvardsen E, Hamre H, Ikdahl T, Fosså 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2012)
10
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01749774
Other Study ID Numbers  ICMJE 2011/2008a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lene Thorsen, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Norwegian School of Sport Sciences
  • Gjensidigestiftelsen
  • The Research Council of Norway
Investigators  ICMJE
Principal Investigator: Lene Thorsen, PhD Oslo universty hospital
PRS Account Oslo University Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP