Effectiveness of an Individualized Program of Muscular Strength and Endurance Program for Improving Germ Cell Cancer
- Conditions
- Testicular Germ Cell Cancer
- Interventions
- Device: Aerobic program
- Registration Number
- NCT02433197
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
- Patients programmed to chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic program Aerobic program Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.
- Primary Outcome Measures
Name Time Method Cancer-related fatigue QuickPiper scale 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
Name Time Method Interleukin-6 (IL-6), Interleukin-18 (IL-18), Interleukin-4 (IL-4) and Interleukin-10 (IL 10) 20 min It will be measured in blood samples following clinical standards in 10 ml venous blood
high density lipoprotein (HDL), low density lipoprotein (LDL) cholesterol, triglycerides 20 min It will be measured in blood samples following clinical standards in 10 ml venous blood
Sf-12 10 min The state of physical and mental health
EuroQoL-5D 10 min Quality of life
C-reactive protein (CRP) 20 min It will be measured in blood samples following clinical standards in 10 ml venous blood
Tumor Necrosis Factor alpha (TNF-a) 20 min It will be measured in blood samples following clinical standards in 10 ml venous blood sample.
Profile of Mood States 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
Physical condition test 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
Trial Locations
- Locations (1)
Antonio Cuesta-Vargas
🇪🇸Malaga, Spain