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Physical Activity and Testicular Cancer

Primary Purpose

Testicular Cancer

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Physical activity counseling

About this trial

This is an interventional supportive care trial for Testicular Cancer focused on measuring Physical activity, Testicular cancer, Chemotherapy, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Oslo university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity counseling

Arm Description

Outcomes

Primary Outcome Measures

Muscle strength, 1RM (one-repetition-maximum)

Change in 1RM from baseline to post-intervention and follow-up

Secondary Outcome Measures

Cardio respiratory fitness (VO2max)

Change in VO2max from baseline to post-intervention and follow-up

Body composition (Lean body mass and fat mass)

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)

Change in metabolic disease markers from baseline to post-intervention and follow-up

C-reactive protein (CRP)

Change in CRP from baseline to post-intervention and follow-up

Creatinkinase (CK)

Change in CK from baseline to post-intervention and follow-up

Creatinkinase - MB (CK-MB)

Change in CK-MB from baseline to post-intervention and follow-up

Myoglobin

Change in myoglobin from baseline to post-intervention and follow-up

Work status

Change in work status from baseline to post-intervention and follow-up

Fatigue

Change in fatigue from baseline to post-intervention and follow-up

Anxiety and depression

Change in anxiety and depression from baseline to post-intervention and follow-up

Quality of life

Change in quality of life from baseline to post-intervention and follow-up

Full Information

NCT ID

NCT01749774

First Posted

November 30, 2012

Last Updated

October 15, 2014

Sponsor

Oslo University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01749774

Brief Title

Physical Activity and Testicular Cancer

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 Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Testicular Cancer

Keywords

Physical activity, Testicular cancer, Chemotherapy, Feasibility

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical activity counseling

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Physical activity counseling

Primary Outcome Measure Information:

Title

Muscle strength, 1RM (one-repetition-maximum)

Description

Change in 1RM from baseline to post-intervention and follow-up

Time Frame

Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)

Secondary Outcome Measure Information:

Title

Cardio respiratory fitness (VO2max)

Description

Change in VO2max from baseline to post-intervention and follow-up

Time Frame