NCT02433197

Brief Summary

Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with GCC undergoing treatment with chemotherapy. Although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited. Methods/Design: The present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. All variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. Besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below 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

April 13, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

April 13, 2015

Last Update Submit

April 2, 2026

Conditions

Testicular Germ Cell Cancer

Keywords

Testicular cancerGerm cell cancerPhysical exerciseCancer-related fatigueChemotherapyClinical rulesMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Cancer-related fatigue QuickPiper scale

    The primary outcome will be fatigue, assessed by the revised Cancer-related fatigue QuickPiper scale, with the semi-structured interview used by Cella et al (1998) to define phenotype of CRF

    20 minutes

Secondary Outcomes (8)

  • Sf-12

    10 min

  • EuroQoL-5D

    10 min

  • Profile of Mood States

    10 min

  • Physical condition test

    20 min

  • C-reactive protein (CRP)

    20 min

  • +3 more secondary outcomes

Study Arms (2)

Aerobic program

EXPERIMENTAL

Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.

Device: Aerobic program

Control group

NO INTERVENTION

They will be instructed to continue their current activities and not to increase objectively levels of physical activity performed during the 8-week intervention.

Interventions

Aerobic programDEVICE

The intervention will be an 8-week program of individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. Each program will be individualized based on the evaluations of muscular strength and enduranceas well as determination of aerobic-anaerobic zone transition described in previous studies In sessions of one hour 3 times a week. Each session will consist of 30 minutes of exercises performed on land followed by 20 minutes of continuous running in treadmill. In week 1 and 2 participants carry out 3 sets of 15 repetitions (reps) to become familiar with the exercises. From week 3 onwards participants will perform 4 sets of 10 reps. If the participant can do more than 12 reps, weight will be increased. All exercises are conducted supervised to ensure proper technique and adequate progression.

Aerobic program

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients programmed to chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Cuesta-Vargas

Málaga, 29009, Spain

Location

Related Publications (1)

  • Cuesta-Vargas AI, Carabantes F, Caracuel Z, Conejo I, Alba E. Effectiveness of an individualized program of muscular strength and endurance with aerobic training for improving germ cell cancer-related fatigue in men undergoing chemotherapy: EFICATEST study protocol for a randomized controlled trial. Trials. 2016 Jan 5;17:8. doi: 10.1186/s13063-015-1143-x.

    PMID: 26732120DERIVED

MeSH Terms

Conditions

Testicular NeoplasmsNeoplasms, Germ Cell and EmbryonalMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antonio I Cuesta-Vargas

    University of Malaga

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Faculty of Health Sciences

Study Record Dates

First Submitted

April 13, 2015

First Posted

May 4, 2015

Study Start

December 1, 2015

Primary Completion

April 1, 2019

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

ES(1)