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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Malaga
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Cancer-related fatigue QuickPiper scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients programmed to chemotherapy
Exclusion Criteria
- Not provided
Arms & Interventions
Aerobic program
Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.
Intervention: Aerobic program (Device)
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.
Outcomes
Primary Outcomes
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
- Interleukin-6 (IL-6), Interleukin-18 (IL-18), Interleukin-4 (IL-4) and Interleukin-10 (IL 10)(20 min)
- high density lipoprotein (HDL), low density lipoprotein (LDL) cholesterol, triglycerides(20 min)
- Sf-12(10 min)
- EuroQoL-5D(10 min)
- C-reactive protein (CRP)(20 min)
- Tumor Necrosis Factor alpha (TNF-a)(20 min)
- Profile of Mood States(10 min)
- Physical condition test(20 min)
Investigators
Dr. Antonio I Cuesta-Vargas
Professor of Faculty of Health Sciences
University of Malaga