WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Gynecologic Cancer; Cachexia

Treatments: Other: Whole-Body Electromyostimulation (WB-EMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03570242

Gyn EMS

Details and patient eligibility

About

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function, quality of life, fatigue and Inflammatory status on patients with gynecological cancer undergoing palliative anti-cancer Treatment. Furthermore, this study assesses the effect of this combined therapeutic approach within a 3 to 4-week pre-operative study Intervention on the period of hospitalization in gynecological patients undergoing curative anti-cancer Treatment.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients with gynecological cancer undergoing palliative or curative treatment
• 18 years and older
• ECOG status > 2

Exclusion criteria

• simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
• acute cardiovascular events
• use of anabolic medications
• epilepsy
• severe neurological diseases
• skin lesions in the area of electrodes
• energy active metals in body
• pregnancy
• acute vein thrombosis
• rheumatic diseases
• pregnant and nursing women
• psychiatric disorders with doubts about legal and cognitive capacity

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Control group (palliative treatment)

No Intervention group

Description:

"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)

WB-EMS group (palliative treatment)

Experimental group

Description:

physical exercise group (includes patients undergoing palliative Treatment) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight)

Treatment:

Other: Whole-Body Electromyostimulation (WB-EMS)

Control group (curative treatment)

No Intervention group

Description:

"usual care" control group (includes patients undergoing curative treatment 3-4 weeks before surgery) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)

WB-EMS group (curative treatment)

Experimental group

Description:

physical exercise group (includes patients undergoing adjuvant treatment 3-4 weeks before surgery) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight)

Treatment:

Other: Whole-Body Electromyostimulation (WB-EMS)