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Physical Activity and Testicular Cancer

This study has been completed.
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
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: October 15, 2014
Last verified: October 2014
  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:


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


Enrollment: 13
Study Start Date: December 2012
Study Completion Date: June 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749774

Locations
Norway
Oslo university hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
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: October 15, 2014
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
Endocrine System Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms
Neoplasms by Site
Testicular Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014