Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy

Cancer Clinical Trial

— PROTECT  

Official title:

Effects of a Protein-rich Individualized Nutritional Therapy Combined With Different Time-efficient Exercise Programs on Physical Fitness, Inflammation and Muscle Status in Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04065815
• Other study ID #: PROTECT-Study
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Hans Joachim Herrmann, Dr.
• Phone: +49 9131 8545218
• Email: hans.herrmann[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• malignant disease (solid or hematological cancer): 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 or Graft-versus-Host-Disease after bone marrow transplantation

• ongoing or planned curative or palliative anti-cancer therapy

• ECOG-Status 0-2

Exclusion Criteria:

• simultaneous participation in other nutritional or exercise intervention Trials

• bone metastases with high fracture risk

• cardiovascular disease

• use of anabolic medications

• epilepsy

• severe neurological or rheumatic 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
• Inflammation

Intervention

Other:
• Resistance Training
Conventional Resistance Training: Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a resistance training program consisting of five exercises: exercises (chest, upper/lower back, abdominals, legs) 1 set per exercise time-effort per session: ~20 min 2 training sessions per week
• WB-EMS
Whole-Body Electromyostimulation (WB-EMS): Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with WB-EMS training: Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; patients perform simple exercises during the stimulation period following a video tutorial time-effort per session: ~20 min 2 training sessions per week
• High-intensity interval training (HIIT)
HIIT: Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with high-intensity interval training (HIIT): supervised cycle-ergometer training at at 80-95% HRmax time-effort per session: ~15 min 2 training sessions per week
• Combined HIIT and Resistance Training (Combi)
HIIT combined with conventional Resistance Training: Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a combined HIIT and resistance training program: HIIT: supervised cycle-ergometer training at at 80-95% HRmax time-effort per session: ~15 min 1 training session per week Resistance Training: five exercises: exercises (chest, upper/lower back, abdominals, legs) 1 set per exercise time-effort per session: ~20 min 1 training session per week

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports	Erlangen

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	Overall physical fitness	Cardiorespiratory Fitness and Muscular Fitness (Overall Fitness Score is calculated from Maximum Oxygen uptake, VO2max, and Muscle strength (estimated from the 1-repetition Maximum - the maximum amount of weight [kg] that can be lifted for one repetition) of the five major muscle groups (chest, upper back, lower back, abdominals, legs)	12 weeks
Secondary	Muscle mass	Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)	12 weeks
Secondary	Fat mass	Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)	12 weeks
Secondary	Total Body Water	Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)	12 weeks
Secondary	Patient-reported performance status-1	Patient-reported performance Status will be assessed using the ECOG Performance Status questionnaire. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. The score ranges from 0-5 (lower values = better outcome).	12 weeks
Secondary	Patient-reported performance status-2	Patient-reported performance status-2 will be assessed using the Karnofsky index. It is used methods to assess the functional status of a Patient. The score ranges from 0-100 (higher value = better outcome).	12 weeks
Secondary	Patient-reported Quality of Life (QoL)	Patient-reported QoL will be assessed using the EORTC QLQ-C30 questionnaire. It contains 30 questions (items), representing various aspects/dimensions of QoL (physical, role, emotional, cognitive and social), and 3 symptom scales (fatigue, pain and nausea).The scales of the different dimensions of QoL (higher values = better outcome) and symptoms (lower values = better outcomes) range from 0-100.	12 weeks
Secondary	Patient-reported Fatigue	Fatigue will be assessed using the FACIT-Fatigue scale. It contains 13 items (different aspects/dimensions of fatigue) each assessed on a scale of 0-4, with lower values indicating a better outcome).	12 weeks
Secondary	Patient-reported Physical Activity	Patient-reported Physical Activity (PA) will be assessed using the the International Physical Activity Questionnaire (IPAQ). IPAQ records 4 aspects of PA (job-, transportation-, housework-, and leisure-time-related). There are two forms of output from scoring the IPAQ. Results can be reported in categories (low, moderate or high PA levels) or as a continuous variable (MET minutes a week, 1 MET = resting energy expenditure). MET minutes represent the amount of energy expended carrying out physical activity. High PA = at least 1500 MET minutes/week; moderate PA: at least 600 MET minutes/week; low PA: < 600 MET minutes/week. Higher values represent a better outcome.	12 weeks
Secondary	Objective Physical Activity	Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.	12 weeks
Secondary	Inflammatory blood markers	Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity creactive protein (hs-CRP).	12 weeks
Secondary	Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)	MetS will be calculated MetS-Z-Score will be calculated from each individual's measures of waist circumference (cm), mean arterial blood pressure (mmHg), blood levels of glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/ dL), based on equations specific to sex.	12 weeks