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

University of Malaga

Status: Suspended

Conditions: Testicular Germ Cell Cancer

Treatments: Device: Aerobic program

Study type: Interventional

Funder types: Other

Identifiers

NCT02433197

FCCSS-UMA_04-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients programmed to chemotherapy

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Aerobic program

Experimental group

Description:

Individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants.

Treatment:

Device: Aerobic program

Control group

No Intervention group

Description:

They will be instructed to continue their current activities and not to increase objectively levels of physical activity performed during the 8-week intervention.