WB-EMS and Nutrition in Patients With Hematological Malignancies

Cancer Clinical Trial

Official title:

Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03556748
• Other study ID #: EMS Nutr hemato onko
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation

• Interval until Transplantation: 6 weeks

• ECOG Status 0-2

Exclusion Criteria:

• patients with serious osteolytic lesions and increased risk of fall

• 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

• acute vein thrombosis

• rheumatic diseases

• pregnant and nursing women

• psychiatric disorders with doubts about legal and cognitive capacity

Related Conditions & MeSH terms

• Cachexia
• Cachexia; Cancer
• Cancer
• Hematologic Diseases
• Leukemia
• Lymphoma
• Myeloma
• Neoplasms

Intervention

Other:
• whole-body electromyostimulation
WB-EMS training is performed 2x/week for a total of 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle mass	Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)	12 weeks
Secondary	Physical function - Isometric muscle strength	Hand grip strength assessed by hand dynamometer (in kg)	12 weeks
Secondary	Cardiorespiratory Fitness	VO2max assessed by spirometry	12 weeks
Secondary	Patient-reported Quality of Life (QoL)	EORTC QLQ - C30 questionnaire	12 weeks
Secondary	Patient-reported Fatigue	FACIT-Fatigue scale	12 weeks
Secondary	Depression/Anxiety	Hospital Anxiety and Depression Scale	12 weeks
Secondary	Inflammatory blood markers	Blood collection and analysis (Albumin, CRP, Cytokines)	12 weeks