Physical Activity and Testicular Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Testicular Cancer
• Intervention / Treatment: Behavioral: Physical activity counseling

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Research Council of Norway; Norwegian School of Sport Sciences; Gjensidigestiftelsen
• Investigators: Principal Investigator: Lene Thorsen, PhD, Oslo universty hospital

Publications and helpful links

General Publications

• Thorsen L, Kirkegaard C, Loge JH, Kiserud CE, Johansen ML, Gjerset GM, Edvardsen E, Hamre H, Ikdahl T, Fossa SD. Feasibility of a physical activity intervention during and shortly after chemotherapy for testicular cancer. BMC Res Notes. 2017 Jun 15;10(1):214. doi: 10.1186/s13104-017-2531-y.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Feasibility; Physical activity; Chemotherapy; Testicular cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Testicular Neoplasms
• Other Study ID Numbers: 2011/2008a