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

Primary Purpose

Cancer, Cancer Cachexia, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Resistance Training
WB-EMS
High-intensity interval training (HIIT)
Combined HIIT and Resistance Training (Combi)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Cachexia, Cardiorespiratory Fitness, Nutrition, Protein intake, Muscular strength, Body composition, High-intensity interval training, Physical exercise, Resistance exercise, whole-body electromyostimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Resistance Training (RT)

WB-EMS

High-intensity interval training (HIIT)

Combined HIIT and Resistance Training (Combi)

Arm Description

Individualized, protein-rich nutritional therapy combined with resistance training

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Muscle mass
Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Fat mass
Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Total Body Water
Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)
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).
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).
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.
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).
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.
Objective Physical Activity
Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
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).
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.

Full Information

First Posted
May 15, 2019
Last Updated
August 21, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04065815
Brief Title
Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment parallel-group, randomized-controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training (RT)
Arm Type
Experimental
Arm Description
Individualized, protein-rich nutritional therapy combined with resistance training
Arm Title
WB-EMS
Arm Type
Experimental
Arm Description
Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)
Arm Title
High-intensity interval training (HIIT)
Arm Type
Experimental
Arm Description
Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)
Arm Title
Combined HIIT and Resistance Training (Combi)
Arm Type
Experimental
Arm Description
Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
WB-EMS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
High-intensity interval training (HIIT)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Combined HIIT and Resistance Training (Combi)
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall physical fitness
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle mass
Description
Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Time Frame
12 weeks
Title
Fat mass
Description
Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Time Frame
12 weeks
Title
Total Body Water
Description
Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)
Time Frame
12 weeks
Title
Patient-reported performance status-1
Description
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).
Time Frame
12 weeks
Title
Patient-reported performance status-2
Description
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).
Time Frame
12 weeks
Title
Patient-reported Quality of Life (QoL)
Description
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.
Time Frame
12 weeks
Title
Patient-reported Fatigue
Description
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).
Time Frame
12 weeks
Title
Patient-reported Physical Activity
Description
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.
Time Frame
12 weeks
Title
Objective Physical Activity
Description
Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
Time Frame
12 weeks
Title
Inflammatory blood markers
Description
Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity creactive protein (hs-CRP).
Time Frame
12 weeks
Title
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Joachim Herrmann, Dr.
Phone
+49 9131 8545218
Email
hans.herrmann@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdagül Zopf, Prof.
Phone
+49 9131 8545218
Email
yurdaguel.zopf@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yurdagül Zopf, Prof.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Joachim Herrmann, Dr.
Phone
+49 9131 8545218
Email
hans.herrmann@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Phone
+49 9131 8545218
Email
dejan.reljic@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35868017
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.
Results Reference
derived

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

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