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Completed

NCT Number: NCT01749774

Physical Activity and Testicular Cancer

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.

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Key information

Conditions

Testicular Cancer Behavior Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oslo university hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity counseling

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Gjensidigestiftelsen
  • Norwegian School of Sport Sciences
  • The Research Council of Norway

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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