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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Overall physical fitness
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •severe neurological or rheumatic diseases
- •skin lesions in the area of electrodes
- •energy active metals in body
- •pregnancy
- •acute vein thrombosis
Arms & Interventions
Resistance Training (RT)
Individualized, protein-rich nutritional therapy combined with resistance training
Intervention: Resistance Training (Other)
WB-EMS
Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)
Intervention: WB-EMS (Other)
High-intensity interval training (HIIT)
Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)
Intervention: High-intensity interval training (HIIT) (Other)
Combined HIIT and Resistance Training (Combi)
Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training
Intervention: Combined HIIT and Resistance Training (Combi) (Other)
Outcomes
Primary Outcomes
Overall physical fitness
Time Frame: 12 weeks
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)
Secondary Outcomes
- Patient-reported Quality of Life (QoL)(12 weeks)
- Patient-reported Fatigue(12 weeks)
- Patient-reported performance status-1(12 weeks)
- Patient-reported Physical Activity(12 weeks)
- Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)(12 weeks)
- Fat mass(12 weeks)
- Total Body Water(12 weeks)
- Patient-reported performance status-2(12 weeks)
- Objective Physical Activity(12 weeks)
- Inflammatory blood markers(12 weeks)
- Muscle mass(12 weeks)