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

Testicular Germ Cell Cancer Clinical Trial

— EFICATEST  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02433197
• Other study ID #: FCCSS-UMA_04-15
• Status: Suspended
• Phase: N/A
• Start date: December 2015

Study information

• Verified date: March 2017
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients programmed to chemotherapy

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Cancer
• Testicular Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Antonio Cuesta-Vargas	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sf-12	The state of physical and mental health	10 min
Secondary	EuroQoL-5D	Quality of life	10 min
Secondary	Profile of Mood States	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	10 min
Secondary	Physical condition test	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	20 min
Secondary	C-reactive protein (CRP)	It will be measured in blood samples following clinical standards in 10 ml venous blood	20 min
Secondary	Tumor Necrosis Factor alpha (TNF-a)	It will be measured in blood samples following clinical standards in 10 ml venous blood sample.	20 min
Secondary	Interleukin-6 (IL-6), Interleukin-18 (IL-18), Interleukin-4 (IL-4) and Interleukin-10 (IL 10)	It will be measured in blood samples following clinical standards in 10 ml venous blood	20 min
Secondary	high density lipoprotein (HDL), low density lipoprotein (LDL) cholesterol, triglycerides	It will be measured in blood samples following clinical standards in 10 ml venous blood	20 min