Clinical trial NCT01749774: 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
Overall status: COMPLETED
Phase: NA
Conditions: Testicular Cancer
Keywords: Physical activity
Testicular cancer
Chemotherapy
Feasibility
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: Gjensidigestiftelsen
name: The Research Council of Norway
First posted: 2012-12-17
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength, 1RM (one-repetition-maximum)
timeFrame: Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)
Secondary outcomes:
measure: Cardio respiratory fitness (VO2max)
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Body composition (Lean body mass and fat mass)
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Metabolic disease markers (blood pressure, body mass index, glucose, high density lipoprotein cholesterol, triglycerides)
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: C-reactive protein (CRP)
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Creatinkinase (CK)
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Creatinkinase - MB (CK-MB)
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Myoglobin
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Work status
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Fatigue
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Anxiety and depression
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
measure: Quality of life
timeFrame: Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
Study officials:
affiliation: Oslo universty hospital
name: Lene Thorsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.