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

NCT03151291 | Unknown

• 1 other identifier: EMS and DS Tumor 01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Cancer Cachexia; Weight Loss; Muscle Loss; Muscle Weakness

Keywords

cancer cachexia; WB-EMS; skeletal muscle mass; exercise; nutrition; dietary supplements

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle mass

  Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

  12 weeks

Secondary Outcomes (7)

• Physical function - isometric muscle strength

  12 weeks

• Physical function - Endurance

  12 weeks

• Physical function - Lower limb strength

  12 weeks

• Patient-reported performance status

  12 weeks

• Patient-reported Quality of Life (QoL)

  12 weeks

Study Arms (8)

Control group

NO INTERVENTION

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

EMS group

EXPERIMENTAL

physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) \+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

Other: Whole-Body Electromyostimulation (WB-EMS)

HMB group

EXPERIMENTAL

HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)

HMB+EMS group

EXPERIMENTAL

HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) \+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB); Other: Whole-Body Electromyostimulation (WB-EMS)

LC group

EXPERIMENTAL

LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

Dietary Supplement: L-carnitine (LC)

LC+EMS group

EXPERIMENTAL

LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) \+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

Dietary Supplement: L-carnitine (LC); Other: Whole-Body Electromyostimulation (WB-EMS)

EPA group

EXPERIMENTAL

EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

Dietary Supplement: Eicosapentaenoic acid (EPA)

EPA+EMS group

EXPERIMENTAL

EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) \+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

Dietary Supplement: Eicosapentaenoic acid (EPA); Other: Whole-Body Electromyostimulation (WB-EMS)

Interventions

β-hydroxy-β-methylbutyrate (HMB) DIETARY_SUPPLEMENT

daily intake of 3 g HMB

HMB group; HMB+EMS group

L-carnitine (LC) DIETARY_SUPPLEMENT

daily intake of 4 g LC

LC group; LC+EMS group

Eicosapentaenoic acid (EPA) DIETARY_SUPPLEMENT

daily intake of 2.2 g EPA

EPA group; EPA+EMS group

Whole-Body Electromyostimulation (WB-EMS) OTHER

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

EMS group; EPA+EMS group; HMB+EMS group; LC+EMS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Hector-Center for Nutrition, Exercise and Sports

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms; Weight Loss; Muscular Atrophy; Muscle Weakness; Motor Activity

Interventions

Carnitine; Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Yurdagül Zopf, Prof. Dr. med.

CONTACT

+49 9131 85-45218; yurdaguel.zopf@uk-erlangen.de

Hans Joachim Herrmann, Dr. oec. troph.

CONTACT

+49 9131 85-45017; hans.herrmann@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 12, 2017
• Study Start: December 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: April 1, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)