Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Malnutrition

Head and Neck Neoplasms

Body Weight

CBCT: before radiotherapy and once a week during radiotherapy

Body weight: before radiotherapy and once a week during radiotherapy

The Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy.

Intensity-modulated radiation therapy (IMRT)

Radical radiotherapy

Yi Pan, Prof.

YI PAN

YI PAN, Prof.

Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss.

Cone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.

This is a prospective observational phase II study. Patients with locally advanced HNC scheduled to receive radical radiotherapy are prospectively enrolled in this study. CBCT and body weight are obtained before radiotherapy and once a week during radiotherapy. Severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.

Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy

Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study

The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.

The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy

The association between Loss of SMM and PG-SGA in HNC patients during radiotherapy. The PG-SGA scores typically range from 0-35, with a higher score reflecting a greater risk of malnutrition.

The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy

The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy

Guangdong Provincial People's Hospital

Prof.

Musculoskeletal Diseases

Nervous System Diseases

Weight Loss

Muscle Weakness

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

physical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min)

+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment

Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Effects of Whole-Body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Support on Patients With Malignant Disease Undergoing Curative or Palliative Anti-cancer Treatment

Hand grip strength assessed by hand dynamometer (in kg)

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

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

Benzocaine

Tannic Acid

Subjects will add certain foods to what they normally eat.

Subjects will be asked to consume certain foods during chemotherapy treatment.

Intervention

Vera Mazurak, Ph.D.

In a person with cancer, low muscle mass and strength increases the risks of suffering from severe complications of the disease, its treatment, and dying. To prevent muscle loss in cancer, stimulating muscle protein anabolism (growth) by fueling muscles with protein is crucial. Dairy products are not only a source of high-quality protein but are a preferred food choice for cancer patients as they progress through chemotherapy treatment. Although commercially available oral nutritional supplements containing essential amino acids are often promoted for protein anabolism, these products are not preferred by cancer patients. Moreover, our research group has shown that patients consuming oral nutritional supplements actually lose more weight than those who chose regular whole-food items. Evidence of the health effects of consuming dairy products is needed to influence dietary recommendations for people with cancer. The objective of our study is to perform a clinical trial to evaluate the efficacy of dairy products to maintain muscle mass and strength and improve patient outcomes in people undergoing chemotherapy treatment for cancer.

Muscle wasting is prevalent among cancer patients and cancer treatment can lead to further muscle depletion which is associated with poor outcomes. Dairy products contain complete proteins of high quality and our previous study has shown a preference for dairy products in cancer patients during cancer treatment. This study aims to demonstrate a proof of principle that consumption of a diet high in protein and rich in dairy products will support the maintenance of muscle mass and strength, therefore improving outcomes in cancer patients undergoing treatment.

Methods: The primary outcome is change in muscle mass during cisplatin and/or immunotherapy treatment. Skeletal muscle index was measured by computed tomography (CT). To assess the physical function and muscle strength of patients, short physical performance battery and hand-held dynamometry tests were performed. Patients whose habitual protein intakes were low, received individual dietary instruction from a registered dietician on how to achieve at least one meal per day consisting of a minimum of 30 g of protein derived from at least 50% dairy products as well as 50% of total protein intake from dairy. Patients in a conventional control group continued their habitual dietary intake along with the standard of care. Subjects in the intervention group began consuming their diets immediately after all baseline measurements were collected and continued through treatment, lasting until their follow-up CT scan.

Results: This trial is in progress. It is expected that high protein diet rich in dairy products can maintain patient muscle mass and strength during chemotherapy compared to a low protein diet.

Conclusions: This study will represent a food based nutrition intervention that addresses limiting nutrients to improve outcomes for cancer patients.

Modifying Your Diet to Support Muscle During Cancer Treatment.

Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer

CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment

Short physical performance battery protocol

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)

Patient Generated Subjective Global Assessment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy	NCT05126095	Head and Neck C... Radiotherapy; A...	Radical radioth...	18 Years -	Guangdong Provincial People's Hospital
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
Effects of WB-EMS and Dietetic Treatment on Cancer Patients	NCT02293239	Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness	Whole-Body Elec...	18 Years -	University of Erlangen-Nürnberg Medical School
Effects of WB-EMS and Dietetic Treatment on Cancer Patients	NCT02293239	Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness	Whole-Body Elec...	18 Years -	University of Erlangen-Nürnberg Medical School
Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy	NCT05126095	Head and Neck C... Radiotherapy; A...	Radical radioth...	18 Years -	Guangdong Provincial People's Hospital
Modifying Your Diet to Support Muscle During Cancer Treatment.	NCT03010657	Non-Small Cell ...	Intervention	18 Years -	University of Alberta

Spots Global Cancer Trial Database for skeletal muscle mass