Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Nervous System Diseases

Nutritional and Metabolic Diseases

Weight Loss

Muscle Weakness

Body Weight

Paresis

Asthenia

Wasting Syndrome

Cachexia

Syndrome

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

Carnitine

"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)

β-hydroxy-β-methylbutyrate (HMB)

L-carnitine (LC)

Eicosapentaenoic acid (EPA)

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

Whole-Body Electromyostimulation (WB-EMS)

Yurdagül Zopf, Prof. Dr. med.

Hans Joachim Herrmann, Dr. oec. troph.

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.

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

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

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

Isometric hand grip strength assessed by hand Dynamometer (in kg)

Six-minute-walk test (walking distance in m)

30 second sit-to-stand test (number of sit-to-stand cycles)

Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin

University of Erlangen-Nürnberg Medical School

Neoplasms

Colonic Polyps

Polyps

Adenomatous Polyps

Pathological Conditions, Anatomical

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

Anti-Infective Agents

Herbal and Botanical

Liver Extracts

Carbamide Peroxide

Cola

Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)

Eicosapentaenoic Acid (EPA)

Endoscopy

9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.

Biopsies taken

Full blood count at baseline, month 3 and month 6.

Clinical chemistry

Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

Haematology

Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

Physical examination

Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

Vital signs

For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

Urine pregnancy test

Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

Completion of patient diary card

Nicholas J West, MB BS FRCS

The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.

Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells.

Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).

Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.

Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

The Effect of Two Dose Levels of Eicosapentaenoic Acid (EPA) on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients	NCT03151291	Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness	β-hydroxy-β-met... L-carnitine (LC... Eicosapentaenoi... Whole-Body Elec...	18 Years -	University of Erlangen-Nürnberg Medical School
Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa	NCT00432913	Adenomatous Pol...	Eicosapentaenoi... Endoscopy Biopsies taken Clinical chemis... Haematology Physical examin... Vital signs Urine pregnancy... Completion of p...	18 Years -	S.L.A. Pharma AG

Spots Global Cancer Trial Database for eicosapentaenoic acid (epa)