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

NCT04065815 | Unknown

• 1 other identifier: PROTECT-Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Muscle mass

  12 weeks

• Fat mass

  12 weeks

• Total Body Water

  12 weeks

• Patient-reported performance status-1

  12 weeks

• Patient-reported performance status-2

  12 weeks

Study Arms (4)

Resistance Training (RT)

EXPERIMENTAL

Individualized, protein-rich nutritional therapy combined with resistance training

Other: Resistance Training

WB-EMS

EXPERIMENTAL

Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)

Other: WB-EMS

High-intensity interval training (HIIT)

EXPERIMENTAL

Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)

Other: High-intensity interval training (HIIT)

Combined HIIT and Resistance Training (Combi)

EXPERIMENTAL

Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training

Other: Combined HIIT and Resistance Training (Combi)

Interventions

Resistance Training OTHER

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

Resistance Training (RT)

WB-EMS OTHER

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

WB-EMS

High-intensity interval training (HIIT) OTHER

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

High-intensity interval training (HIIT)

Combined HIIT and Resistance Training (Combi) OTHER

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

Combined HIIT and Resistance Training (Combi)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports

Erlangen, 91054, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 35868017 DERIVED

MeSH Terms

Conditions

Neoplasms; Inflammation; Cachexia; Motor Activity

Interventions

Resistance Training; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dejan Reljic, Dr.

  University Erlangen Nuremberg Medical School

  PRINCIPAL INVESTIGATOR

• Yurdagül Zopf, Prof.

  University Erlangen Nuremberg Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Joachim Herrmann, Dr.

CONTACT

+49 9131 8545218; hans.herrmann@uk-erlangen.de

Yurdagül Zopf, Prof.

CONTACT

+49 9131 8545218; yurdaguel.zopf@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment parallel-group, randomized-controlled study

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: August 22, 2019
• Study Start: May 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)