NCT01749774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

November 30, 2012

Last Update Submit

October 15, 2014

Conditions

Testicular Cancer

Keywords

Physical activityTesticular cancerChemotherapyFeasibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Cardio respiratory fitness (VO2max)

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

  • Body composition (Lean body mass and fat mass)

    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)

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

  • C-reactive protein (CRP)

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

  • Creatinkinase (CK)

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

  • +6 more secondary outcomes

Study Arms (1)

Physical activity counseling

EXPERIMENTAL
Behavioral: Physical activity counseling

Interventions

Physical activity counselingBEHAVIORAL
Physical activity counseling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seminoma/non-seminoma
  • Stage II-IV
  • BEP(bleomycin,etoposide and cisplatin)or 4 EP(etoposide and cisplatin)
  • \> 18 years
  • Capable of reading and writing Norwegian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28619116DERIVED

MeSH Terms

Conditions

Testicular NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersBehavior

Study Officials

  • Lene Thorsen, PhD

    Oslo universty hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 17, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

NO(1)