Clinical trial NCT02433197: Effectiveness of an Individualized Program of Muscular Strength and Endurance Program for Improving Germ Cell Cancer
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 type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Testicular Germ Cell Cancer
Keywords: Testicular cancer
Germ cell cancer
Physical exercise
Cancer-related fatigue
Chemotherapy
Clinical rules
Metabolomics
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients programmed to chemotherapy

Exclusion Criteria:

-

Primary outcomes:
measure: Cancer-related fatigue QuickPiper scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Sf-12
timeFrame: 10 min
measure: EuroQoL-5D
timeFrame: 10 min
measure: Profile of Mood States
timeFrame: 10 min
measure: Physical condition test
timeFrame: 20 min
measure: C-reactive protein (CRP)
timeFrame: 20 min
measure: Tumor Necrosis Factor alpha (TNF-a)
timeFrame: 20 min
measure: Interleukin-6 (IL-6), Interleukin-18 (IL-18), Interleukin-4 (IL-4) and Interleukin-10 (IL 10)
timeFrame: 20 min
measure: high density lipoprotein (HDL), low density lipoprotein (LDL) cholesterol, triglycerides
timeFrame: 20 min
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Antonio Cuesta-Vargas
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta-Vargas
role: STUDY_DIRECTOR
References:
citation: 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.