Clinical trial NCT04065815: Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Cancer Cachexia
Inflammation
Keywords: Cancer
Cachexia
Cardiorespiratory Fitness
Nutrition
Protein intake
Muscular strength
Body composition
High-intensity interval training
Physical exercise
Resistance exercise
whole-body electromyostimulation
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment parallel-group, randomized-controlled study
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall physical fitness
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscle mass
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Total Body Water
timeFrame: 12 weeks
measure: Patient-reported performance status-1
timeFrame: 12 weeks
measure: Patient-reported performance status-2
timeFrame: 12 weeks
measure: Patient-reported Quality of Life (QoL)
timeFrame: 12 weeks
measure: Patient-reported Fatigue
timeFrame: 12 weeks
measure: Patient-reported Physical Activity
timeFrame: 12 weeks
measure: Objective Physical Activity
timeFrame: 12 weeks
measure: Inflammatory blood markers
timeFrame: 12 weeks
measure: Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
Study officials:
affiliation: University Erlangen Nuremberg Medical School
name: Dejan Reljic, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Erlangen Nuremberg Medical School
name: Yurdagül Zopf, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reljic D, Herrmann HJ, Jakobs B, Dieterich W, Mougiakakos D, Neurath MF, Zopf Y. Feasibility, Safety, and Preliminary Efficacy of Very Low-Volume Interval Training in Advanced Cancer Patients. Med Sci Sports Exerc. 2022 Nov 1;54(11):1817-1830. doi: 10.1249/MSS.0000000000002989. Epub 2022 Jul 8.