search
Back to results

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

Primary Purpose

Cancer, Cancer Cachexia, Weight Loss

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
β-hydroxy-β-methylbutyrate (HMB)
L-carnitine (LC)
Eicosapentaenoic acid (EPA)
Whole-Body Electromyostimulation (WB-EMS)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer focused on measuring cancer cachexia, WB-EMS, skeletal muscle mass, exercise, nutrition, dietary supplements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hector-Center for Nutrition, Exercise and SportsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group

EMS group

HMB group

HMB+EMS group

LC group

LC+EMS group

EPA group

EPA+EMS group

Arm Description

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

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)

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)

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)

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical function - isometric muscle strength
Isometric hand grip strength assessed by hand Dynamometer (in kg)
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Patient-reported performance status
ECOG performance status/Karnofsky index
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Patient-reported Fatigue
FACIT-Fatigue scale
Inflammatory blood markers
Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin

Full Information

First Posted
May 11, 2017
Last Updated
October 15, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT03151291
Brief Title
Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness
Keywords
cancer cachexia, WB-EMS, skeletal muscle mass, exercise, nutrition, dietary supplements

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)
Arm Title
EMS group
Arm Type
Experimental
Arm Description
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)
Arm Title
HMB group
Arm Type
Experimental
Arm Description
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)
Arm Title
HMB+EMS group
Arm Type
Experimental
Arm Description
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)
Arm Title
LC group
Arm Type
Experimental
Arm Description
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)
Arm Title
LC+EMS group
Arm Type
Experimental
Arm Description
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)
Arm Title
EPA group
Arm Type
Experimental
Arm Description
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)
Arm Title
EPA+EMS group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
β-hydroxy-β-methylbutyrate (HMB)
Intervention Description
daily intake of 3 g HMB
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine (LC)
Intervention Description
daily intake of 4 g LC
Intervention Type
Dietary Supplement
Intervention Name(s)
Eicosapentaenoic acid (EPA)
Intervention Description
daily intake of 2.2 g EPA
Intervention Type
Other
Intervention Name(s)
Whole-Body Electromyostimulation (WB-EMS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Skeletal muscle mass
Description
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical function - isometric muscle strength
Description
Isometric hand grip strength assessed by hand Dynamometer (in kg)
Time Frame
12 weeks
Title
Physical function - Endurance
Description
Six-minute-walk test (walking distance in m)
Time Frame
12 weeks
Title
Physical function - Lower limb strength
Description
30 second sit-to-stand test (number of sit-to-stand cycles)
Time Frame
12 weeks
Title
Patient-reported performance status
Description
ECOG performance status/Karnofsky index
Time Frame
12 weeks
Title
Patient-reported Quality of Life (QoL)
Description
EORTC QLQ - C30 questionnaire
Time Frame
12 weeks
Title
Patient-reported Fatigue
Description
FACIT-Fatigue scale
Time Frame
12 weeks
Title
Inflammatory blood markers
Description
Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdagül Zopf, Prof. Dr. med.
Phone
+49 9131 85-45218
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Joachim Herrmann, Dr. oec. troph.
Phone
+49 9131 85-45017
Email
hans.herrmann@uk-erlangen.de
Facility Information:
Facility Name
Hector-Center for Nutrition, Exercise and Sports
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdagül Zopf, Prof. Dr. med.
Phone
+49 9131 85-45218
Email
yurdaguel.zopf@k-erlangen.de
First Name & Middle Initial & Last Name & Degree
Hans Joachim Herrmann, Dr. oec. troph.
Phone
+49 9131 85-45017
Email
hans.herrmann@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs