Clinical trial NCT03570242: WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients
Official title: Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Gynecological Cancer Undergoing Curative and Palliative Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Cachexia
Keywords: gynecologic cancer
WB-EMS
whole-body electromyostimulation
nutrition
protein
exercise
cancer cachexia
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Skeletal muscle mass
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Period of hospitalization
timeFrame: 3-4 week (curative treatment)
Secondary outcomes:
measure: Physical function - Isometric muscle strength
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Physical function - Endurance
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Physical function - Lower limb strength
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Patient-reported performance status
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment), Total Score ranges from 0-100 with a higher score indicating better performance status
measure: Patient-reported Quality of Life (QoL)
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Patient-reported Fatigue
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Pain score
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Depression score
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Gastrointestinal toxicity of chemotherapy
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Physical activity
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
measure: Inflammatory status
timeFrame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
References: