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NCT Number: NCT02433197

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

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.

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Key information

Conditions

Testicular Germ Cell Cancer Behavior Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Cuesta-Vargas

Málaga, 29009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients programmed to chemotherapy

Exclusion criteria

-

Treatment and study plan

Aerobic program

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study 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

Acronym: EFICATEST

Important dates

Study start
2015
Primary completion
2019
First posted
May 4, 2015
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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