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

August 21, 2019 updated by: University of Erlangen-Nürnberg Medical School

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance Training (RT)
Individualized, protein-rich nutritional therapy combined with resistance training
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
Experimental: WB-EMS
Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)
Other: 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
Experimental: High-intensity interval training (HIIT)
Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)
Other: 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
Experimental: Combined HIIT and Resistance Training (Combi)
Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported performance status-1
Time Frame: 12 weeks
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
Patient-reported performance status-2
Time Frame: 12 weeks
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
Patient-reported Quality of Life (QoL)
Time Frame: 12 weeks
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
Patient-reported Fatigue
Time Frame: 12 weeks
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
Patient-reported Physical Activity
Time Frame: 12 weeks
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
Muscle mass
Time Frame: 12 weeks
Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
12 weeks
Fat mass
Time Frame: 12 weeks
Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
12 weeks
Total Body Water
Time Frame: 12 weeks
Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)
12 weeks
Objective Physical Activity
Time Frame: 12 weeks
Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
12 weeks
Inflammatory blood markers
Time Frame: 12 weeks
Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity creactive protein (hs-CRP).
12 weeks
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTECT-Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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