Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Cancer Clinical Trial

Official title:

Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151291
• Other study ID #: EMS and DS Tumor 01
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 2019

Study information

• Verified date: October 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Yurdagül Zopf, Prof. Dr. med.
• Phone: +49 9131 85-45218
• Email: yurdaguel.zopf[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer care. Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer. Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• malignant disease (solid or hematological cancer) e.g. head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas

• ECOG Performance Status = 2

Exclusion Criteria:

• simultaneous participation in other nutritional or exercise intervention trials

• 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

Related Conditions & MeSH terms

• Cachexia
• Cancer
• Cancer Cachexia
• Muscle Loss
• Muscle Weakness
• Paresis
• Weight Loss

Intervention

Dietary Supplement:
• ß-hydroxy-ß-methylbutyrate (HMB)
daily intake of 3 g HMB
• L-carnitine (LC)
daily intake of 4 g LC
• Eicosapentaenoic acid (EPA)
daily intake of 2.2 g EPA

Other:
• Whole-Body Electromyostimulation (WB-EMS)
WB-EMS training is performed 2x/week for 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	Hector-Center for Nutrition, Exercise and Sports	Erlangen	Bavaria

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	Isometric hand grip strength assessed by hand Dynamometer (in kg)	12 weeks
Secondary	Physical function - Endurance	Six-minute-walk test (walking distance in m)	12 weeks
Secondary	Physical function - Lower limb strength	30 second sit-to-stand test (number of sit-to-stand cycles)	12 weeks
Secondary	Patient-reported performance status	ECOG performance status/Karnofsky index	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	Inflammatory blood markers	Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin	12 weeks