CancerPROTECTNCT04065815
Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy
A study testing Resistance Training, WB-EMS and High-intensity interval training (HIIT) in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Cachexia, Inflammation
- What is being tested?
- Resistance Training, WB-EMS and High-intensity interval training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- skin lesions in the area of electrodes
- energy active metals in body
- pregnancy
- acute vein thrombosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
Erlangen, 91054
Hans Joachim Herrmann, Dr., +49 9131 8545218, hans.herrmann@uk-erlangen.de
Dejan Reljic, Dr., +49 9131 8545218, dejan.reljic@uk-erlangen.de
About this study
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
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
- Being tested
- Resistance Training, WB-EMS, High-intensity interval training (HIIT), Combined HIIT and Resistance Training (Combi)
- Keywords
- Cancer, Cachexia, Cardiorespiratory Fitness, Nutrition, Protein intake, Muscular strength, Body composition, High-intensity interval training, Physical exercise, Resistance exercise, whole-body electromyostimulation
- Medical subject headings
- Neoplasms, Inflammation, Cachexia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
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
WB-EMSOther
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training (RT) | Experimental | Individualized, protein-rich nutritional therapy combined with resistance training Receives: Other: Resistance Training |
| WB-EMS | Experimental | Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS) Receives: Other: WB-EMS |
| High-intensity interval training (HIIT) | Experimental | Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT) Receives: 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 Receives: Other: Combined HIIT and Resistance Training (Combi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (11)
Muscle mass
Muscle mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Measured: 12 weeks
Fat mass
Fat mass (kg) is assessed by bioelectrical impedance Analysis (BIA)
Measured: 12 weeks
Total Body Water
Total Body Water (L) is assessed by bioelectrical impedance Analysis (BIA)
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Objective Physical Activity
Objective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 May 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dejan Reljic, Dr., Principal investigator, University Erlangen Nuremberg Medical SchoolYurdagül Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065815
- Sponsor's protocol ID
- PROTECT-Study
- Acronym
- PROTECT
- Status last verified
- Aug 2019
- First submitted
- 15 May 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35868017
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04065815
- Acronym / sponsor ID
- PROTECT / PROTECT-Study
- Conditions
- Cancer, Cancer Cachexia, Inflammation
- Keywords
- Cancer, Cachexia, Cardiorespiratory Fitness, Nutrition, Protein intake, Muscular strength, Body composition, High-intensity interval training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Resistance Training (RT) | Experimental | Other: Resistance TrainingIndividualized, protein-rich nutritional therapy combined with resistance training |
| WB-EMS | Experimental | Other: WB-EMSIndividualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS) |
| High-intensity interval training (HIIT) | Experimental | Other: High-intensity interval training (HIIT)Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT) |
| Combined HIIT and Resistance Training (Combi) | Experimental | Other: Combined HIIT and Resistance Training (Combi)Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- simultaneous participation in other nutritional or exercise intervention Trials
- bone metastases with high fracture risk
- cardiovascular disease
- use of anabolic medications
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingConventional 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 | Other | Resistance Training (RT) |
| WB-EMSWhole-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 | Other | WB-EMS |
| 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 | Other | High-intensity interval training (HIIT) |
| 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 | Other | Combined HIIT and Resistance Training (Combi) |
Primary outcome
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)
11 secondary outcomes
Muscle mass
Time frame: 12 weeks
Fat mass
Time frame: 12 weeks
Total Body Water
Time frame: 12 weeks
Patient-reported performance status-1
Time frame: 12 weeks
Patient-reported performance status-2
Time frame: 12 weeks
Patient-reported Quality of Life (QoL)
Time frame: 12 weeks
Patient-reported Fatigue
Time frame: 12 weeks
Patient-reported Physical Activity
Time frame: 12 weeks
Objective Physical Activity
Time frame: 12 weeks
Inflammatory blood markers
Time frame: 12 weeks
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 35868017Reljic 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.
- Individual participant dataSharing planned: No
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dejan Reljic, Dr. principal investigator
University Erlangen Nuremberg Medical School
Yurdagül Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training, WB-EMS and High-intensity interval training (HIIT) in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Joachim Herrmann, Dr. (+49 9131 8545218, hans.herrmann@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall physical fitness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.