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Effectiveness of an Individualized Program of Muscular Strength and Endurance Program for Improving Germ Cell Cancer (EFICATEST)

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ClinicalTrials.gov Identifier: NCT02433197
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga

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.


Condition or disease Intervention/treatment Phase
Testicular Germ Cell Cancer Device: Aerobic program Phase 1 Phase 2

Detailed Description:

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. Our aim is to evaluate the effects of an individualized exercise program with aerobic training in water running on cancer-related fatigue.

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. The investigators will conduct this trial in patients undergoing chemotherapy, recruited by the Departament of Oncology of Virgen de la Victoria Hospital (Málaga). Patients will be included and evaluated before the first cycle of chemotherapy and assigned experimental or control group randomly. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of an Individualized Program of Muscular Strength and Endurance Program With Aerobic Training for Improving Germ Cell Cancer Related Fatigue in Men Undergoing Chemotherapy
Study Start Date : December 2015
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic program
Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.
Device: Aerobic program

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.


No Intervention: Control group
They will be instructed to continue their current activities and not to increase objectively levels of physical activity performed during the 8-week intervention.



Primary Outcome Measures :
  1. Cancer-related fatigue QuickPiper scale [ Time Frame: 20 minutes ]
    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


Secondary Outcome Measures :
  1. Sf-12 [ Time Frame: 10 min ]
    The state of physical and mental health

  2. EuroQoL-5D [ Time Frame: 10 min ]
    Quality of life

  3. Profile of Mood States [ Time Frame: 10 min ]
    It is possible to obtain an overall index of altered mood and seven partial measures: stress / anxiety, depression / rejection, anger / hostility, vigor / activity, fatigue / inertia and confusion / bewilderment

  4. Physical condition test [ Time Frame: 20 min ]
    strength peak of knee extension (quadriceps), knee flexion (hamstring), elbow extension (brachial triceps) and elbow flexion (biceps brachii) by one dynamometry instrumented with Powertruck II of JTECH, following the protocol described by Daniels & Worthingham (1995). Hand grip strength will be evaluated by the hydraulic dynamometer JAMAR

  5. C-reactive protein (CRP) [ Time Frame: 20 min ]
    It will be measured in blood samples following clinical standards in 10 ml venous blood

  6. Tumor Necrosis Factor alpha (TNF-a) [ Time Frame: 20 min ]
    It will be measured in blood samples following clinical standards in 10 ml venous blood sample.

  7. Interleukin-6 (IL-6), Interleukin-18 (IL-18), Interleukin-4 (IL-4) and Interleukin-10 (IL 10) [ Time Frame: 20 min ]
    It will be measured in blood samples following clinical standards in 10 ml venous blood

  8. high density lipoprotein (HDL), low density lipoprotein (LDL) cholesterol, triglycerides [ Time Frame: 20 min ]
    It will be measured in blood samples following clinical standards in 10 ml venous blood



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients programmed to chemotherapy

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433197


Contacts
Contact: Antonio I Cuesta-Vargas, PhD acuesta@uma.es

Locations
Spain
Antonio Cuesta-Vargas Recruiting
Malaga, Spain, 29009
Contact: Antonio Cuesta-Vargas, phD    00349527551    acuesta@uma.es   
Sponsors and Collaborators
University of Malaga
Investigators
Study Director: Antonio I Cuesta-Vargas University of Malaga

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Antonio I Cuesta-Vargas, Professor of Faculty of Health Sciences, University of Malaga
ClinicalTrials.gov Identifier: NCT02433197     History of Changes
Other Study ID Numbers: FCCSS-UMA_04-15
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Dr. Antonio I Cuesta-Vargas, University of Malaga:
Testicular cancer
Germ cell cancer
Physical exercise
Cancer-related fatigue
Chemotherapy
Clinical rules
Metabolomics

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders