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

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ClinicalTrials.gov Identifier: NCT04065815
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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

Condition or disease Intervention/treatment Phase
Cancer Cancer Cachexia Inflammation Other: Resistance Training Other: WB-EMS Other: High-intensity interval training (HIIT) Other: Combined HIIT and Resistance Training (Combi) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment parallel-group, randomized-controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Muscle mass [ Time Frame: 12 weeks ]
    Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)

  2. Fat mass [ Time Frame: 12 weeks ]
    Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)

  3. Total Body Water [ Time Frame: 12 weeks ]
    Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)

  4. 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).

  5. 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).

  6. 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.

  7. 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).

  8. 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.

  9. Objective Physical Activity [ Time Frame: 12 weeks ]
    Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.

  10. 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).

  11. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065815


Contacts
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Contact: Hans Joachim Herrmann, Dr. +49 9131 8545218 hans.herrmann@uk-erlangen.de
Contact: Yurdagül Zopf, Prof. +49 9131 8545218 yurdaguel.zopf@uk-erlangen.de

Locations
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Germany
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports Recruiting
Erlangen, Germany, 91054
Contact: Hans Joachim Herrmann, Dr.    +49 9131 8545218    hans.herrmann@uk-erlangen.de   
Contact: Dejan Reljic, Dr.    +49 9131 8545218    dejan.reljic@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Dejan Reljic, Dr. University Erlangen Nuremberg Medical School
Principal Investigator: Yurdagül Zopf, Prof. University Erlangen Nuremberg Medical School

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04065815     History of Changes
Other Study ID Numbers: PROTECT-Study
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Cancer
Cachexia
Cardiorespiratory Fitness
Nutrition
Protein intake
Muscular strength
Body composition
High-intensity interval training
Physical exercise
Resistance exercise
whole-body electromyostimulation
Additional relevant MeSH terms:
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Wasting Syndrome
Inflammation
Cachexia
Pathologic Processes
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders