Physical Activity and Testicular Cancer

Testicular Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749774
• Other study ID #: 2011/2008a
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: October 15, 2014
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• Study type: Interventional

Clinical 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. It is hypothesized that the patients are able to complete the intervention with individual adjustments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Intervention

Behavioral:
• Physical activity counseling

Locations

Country	Name	City	State
Norway	Oslo university hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Gjensidigestiftelsen, Norwegian School of Sport Sciences, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength, 1RM (one-repetition-maximum)	Change in 1RM from baseline to post-intervention and follow-up	Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Cardio respiratory fitness (VO2max)	Change in VO2max from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Body composition (Lean body mass and fat mass)	Change in body composition from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	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	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	C-reactive protein (CRP)	Change in CRP from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Creatinkinase (CK)	Change in CK from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Creatinkinase - MB (CK-MB)	Change in CK-MB from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Myoglobin	Change in myoglobin from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Work status	Change in work status from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Fatigue	Change in fatigue from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Anxiety and depression	Change in anxiety and depression from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No
Secondary	Quality of life	Change in quality of life from baseline to post-intervention and follow-up	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	No