Physical Activity and Testicular Cancer

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01749774
• Collaborator: Norwegian School of Sport Sciences (Other), Gjensidigestiftelsen (Other), The Research Council of Norway (Other)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Cancer	Behavioral: Physical activity counseling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity counseling	Behavioral: Physical activity counseling

Outcome Measures

Primary Outcome Measures

1. Muscle strength, 1RM (one-repetition-maximum) [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 Outcome Measures

1. Cardio respiratory fitness (VO2max) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lene Thorsen, PhD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01749774
• Other Study ID Numbers: 2011/2008a
• First Posted: Dec 17, 2012
• Last Update Posted: Oct 16, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Lene Thorsen, PhD, Oslo University Hospital: Physical activity; Testicular cancer; Chemotherapy; Feasibility
• Additional relevant MeSH terms: Testicular Neoplasms

Study Results

No Results Posted as of Oct 16, 2014